Flexible low compliance extension tubing for balloon inflation

ABSTRACT

A controlled volume inflation-deflation device to inflate a balloon to occlude a blood vessel by dialing a knob that locks at rotational positions to locate a plunger at equally spaced locations within a syringe of the inflation-deflation device. The inflation-deflation device includes a releasable latch to lock the proximal and distal housings together to hold the plunger forward for occlusion, and to separate and hold the proximal and distal housings to retract the plunger for perfusion. When the inflation-deflation device is returned to the latched position, the balloon is re-inflated to its previous occlusive diameter. Also, an extension tube made of a lower modulus outer material co-extruded over and miscible with a higher modulus inner material may be used to produce a suitably low compliance extension tube for the inflation-deflation device. The balloon may have tapered ends and a cylindrical center portion so that it increases by more equal increments in outer diameter in response to incremental equal increases in inflation volume.

This application is a continuation of U.S. application Ser. No.12/705,556, filed on Feb. 12, 2010, and issued as U.S. Pat. No.8,419,714, on Apr. 16, 2013, which is a divisional of U.S. applicationSer. No. 11/313,477 filed on Dec. 20, 2005 and issued as U.S. Pat. No.7,674,240 on Mar. 9, 2010.

FIELD

Temporary blood vessel occlusion devices and methods.

BACKGROUND

It is increasingly important that a physician or surgeon deliveringsubstances, such as an imaging or treatment agent or drug, is able tosafely, efficiently and accurately occlude a blood vessel at a region ofinterest to visualize or treat a desired target tissue for effectivedelivery of the substance. Moreover, it is also important that thephysician or surgeon is able to efficiently and accurately remove theocclusion of the blood vessel (allow perfusion of the target tissue)after the desired time interval to avoid damage to the desired targettissue, such as by lack of oxygen. This is particularly true when thedesired concentration and/or resident time of the substance required atthe target site cannot be safely and/or effectively achieved byintroduction of the substance to a location remote from the target site.Moreover, the physician may only want to treat the diseased portion ofan organ or tissue to avoid treating any healthy portion. In a similarmanner, a physician or surgeon may use vessel occlusion to selectivelydeliver an imaging agent or transparent flushing fluid to the innerdiameter (ID) of a vessel. For example, an imaging agent may be injectedwith vessel occlusion or partial occlusion to more easily/selectivelyvisualize the vessel “roadmap”, to more easily visualize/measure thetissues that may be subsequently treated, to label a map of such tissuesor to observe/measure the tissues' perfusion and/or clearance/wash outcharacteristics. A transparent flushing fluid may be injected withvessel occlusion, for example, to improve optical coherence tomography(OCT) imaging or the light application of a photodynamic therapy.

For example, to achieve localized treatment of tissue, such as tissue ina heart, physicians and surgeons can use catheters with occlusiondevices, such as balloons. Specifically, blood vessels, such as arteriesand veins, can be temporarily occluded during treatment by inflating aballoon at a region of interest of the vessel to block blood flow andthus avoid or retard the washing away of the imaging or treatment agentor drug by the flowing blood. After treatment, the region of interestmay then be perfused (blood allowed to flow) by deflating the balloon tounblock the vessel.

In some cases, cardiovascular guide catheters are generally percutaneousdevices used to advance through a vasculature of a patient proximal to aregion of interest and are devices through which another catheter ordevice may be inserted. Similarly, guidewires may be advanced through aguide catheter and further into the vasculature, across a vascularregion of interest. Infusion or delivery catheters are generallycatheters used to deliver or infuse a treatment and/or imaging agent toa region of interest in a vasculature of a patient and typically may beengaged with a guidewire and inserted through another catheter (e.g., aguide catheter) and advanced into the vasculature to the desired regionof interest. Moreover, occlusion devices, such as occlusion balloons,may be attached to a guide catheter, a guidewire or an infusion catheterto occlude and then perfuse (remove the occlusion and allow blood flowthrough) a region of interest in a vasculature. Additionally, a guidecatheter or infusion catheter may be used to deliver or infuse atreatment and/or an imaging agent to a region of interest in avasculature of a patient proximal or distal to the occlusion devicebefore, during or after an occlusion.

In addition, an inflation-deflation device may push fluid into andretract fluid from the interior or cavity of the occlusion device orballoon via a catheter to inflate and deflate the occlusion device orballoon (e.g., such as using a lumen or tube in the catheter tocommunicate a fluid between the inflation device and the inner chamberof a balloon). To help control the outer diameter of a balloon and forsafety reasons, the catheter and balloon may be aspirated (remove airand replace it with a fluid) prior to inflating the balloon with fluidto occlude the blood vessel. The fluid most often used to aspirate thecatheter and balloon and inflate the occlusion balloon is contrast or amixture of contrast and saline. Contrast is an imaging agent that allowsthe balloon to be imaged by an imaging modality such as fluoroscopy, MRIor ultrasound. Occlusion of the vessel is generally confirmed byinjecting contrast into the guide catheter and observing by fluoroscopythat none of this contrast flows past the inflated balloon and/or byobserving a pressure change due to the occlusion (i.e. the pressure ofthe blood may be monitored via a lumen of the catheter). Balloons may bemade of a variety of materials and their inflation controlled to createnon-compliant, compliant and elastic balloons. A non-compliant balloon,like those commonly used on balloon dilation catheters, may be used atmoderate or low pressures (compared to dilation pressures) to occlude avessel safely over a very small range of vessel diameters. However,conventional means to determine a vessel's inner diameter (usuallyfluoroscopy) are not highly accurate, especially in eccentricvessels/vessels with atheroma. If the device balloon size chosen is toosmall, then adequate vessel occlusion may not be obtained. If the deviceballoon size chosen is too large, then the vessel wall may beunnecessarily damaged by over expansion in a manner that may result in adissection and/or a subsequent vessel stenosis or restenosis. Generally,a compliant, small volume balloon may be used to allow for more rapidballoon inflations and deflations and for more adjustable balloondiameters to allow vessel occlusion over a wider range of vesseldiameters at lower balloon pressures. Generally, an elastic, smallvolume balloon allows for far more adjustable balloon diameters to allowvessel occlusion over a much wider range of vessel diameters at evenlower balloon pressures. The difference between a compliant balloon andan elastic balloon is that a compliant balloon will not return to verynearly its original uninflated size (OD) or shape after inflation to itsmaximum designed size (OD), whereas an elastic balloon will return toits original uninflated size (OD) and shape after inflation to itsmaximum designed size. Often a compliant balloon will have an initial,pre-insertion, or nominal ID that is larger than the outer diameter (OD)of the catheter/device that it is mounted on and, thus, the compliantballoon will be folded to hug the catheter/device shaft during insertioninto a vessel. Often the ID of an elastic balloon will closely fit tothe OD of the catheter/device that it is mounted on and not requirefolding. Lower inflation pressures are desired, as less pressure is thenavailable to damage/expand the vessel wall, if the balloon is over-sizeddue to an accidental misadjustment, an incorrect vessel sizedetermination or other reasons. As a limit, the inflation pressureapplied to or present in an occlusion balloon may equal or exceed theblood pressure of the vessel to keep the balloon inflated and occludingthat vessel. Small volume balloons are desired because of their morerapid inflation and deflation times at low pressures. A wide range ofballoon diameter adjustment is desired, as fewer devices may be stockedto cover a particular vessel size range (vessel sizes vary in theanatomy and across the population) and the degree of vessel diameterdetermination accuracy required to choose a device that will safelyocclude the vessel is reduced. In some cases, what is desired isinflation/deflation, aspiration, and occlusion balloon devices andprocedures that allow for repeated occlusion and perfusion of a bloodvessel with a low risk of damaging/expanding the vessel wall. Forinstance, there is a need for an occlusion balloon, such as an elasticsmall volume low pressure balloon, that will expand to predictablerepeatable outer diameters in response to being inflated and deflatedwith predictable repeatable amounts of fluid that can be provided by aninflation/deflation device (after successful aspiration).

SUMMARY

There is disclosed an inflation-deflation device for inflating anddeflating an occlusion device or a balloon using increments of selected,controlled, or equal volumes of a fluid. A preferred embodiment of suchan inflation-deflation device, without limitation to any single orcombinations of components or functions thereof, may be a controlledvolume inflation deflation device, such as an “INDEFLATOR®” which is atrademark of Guidant Corporation, 3200 Lakeside Drive, Santa Clara,Calif. 95054-2807. Such an inflation-deflation device may also bereferred to as a controlled volume INDEFLATOR®. The device of thepresent invention can be especially useful when used with compliant orelastic balloons. The controlled volume inflation-deflation device(e.g., controlled volume INDEFLATOR®) may have a syringe, which consistsof a body and a plunger, to push in and retract out volumes of fluidcommunicated with the interior or cavity of the balloon via a catheteror lumen therethrough. The device may also have a releasable latchbetween a proximal portion, which constrains the syringe's plunger via alongitudinal incremental manipulation mechanism, and a distal portion,which constrains the body of the syringe, so that releasing the latchallows for relative motion between the proximal housing and the distalhousing, such that the plunger may be moved a distance into or out ofthe body of the syringe. Specifically the latch may define tworeleasably latched positions to move the plunger a set distance withinthe syringe body.

When the described controlled volume inflation-deflation device is usedto control the diameter of balloons that have an initial or nominaldiameter or a desired initial diameter or inflation that requires aninitial volume of fluid to be injected into the balloon (via a catheter,a communicating lumen and/or cavity), the balloon may be initiallyinflated with another device and then connected to the controlled volumeinflation-deflation device. This connection transition can beaccomplished in the desired manner using a stopcock. For instance, usinga stopcock, a compliant balloon may be initially inflated to its initialor nominal diameter using a conventional inflation-deflation device toinflate the balloon to a low pressure, or using a low volume syringe toinflate the balloon to a given injection volume. Because the diametersof elastic balloons are difficult to control using pressure, the initialinflation of elastic balloons that hug the OD of the catheters that theyare mounted on to an initial OD is preferred to be done using a giveninjection volume.

BRIEF DESCRIPTION OF THE DRAWINGS

Various features, aspects and advantages will become more thoroughlyapparent from the following detailed description, the set of claims, andaccompanying drawings in which:

FIG. 1A is a schematic partial see through side view of a controlledvolume inflation-deflation device having a latch in the first(inflation) latched position.

FIG. 1B is a schematic cross-sectional side view of a portion of thecontrolled volume inflation-deflation device showing an indexing lockengaging a recess.

FIG. 1C is schematic side views and cross-sectional side views ofvarious components of a controlled volume inflation-deflation device.

FIG. 1D is a view of knob 230 along perspective A of FIG. 1C.

FIG. 1E shows a radial spring or o-ring in a groove.

FIG. 2 is a schematic partial see through side view of the controlledvolume inflation-deflation device of FIG. 1 having the latch in a second(deflation) latched position.

FIG. 3 is a schematic partial see through side view of the controlledvolume inflation-deflation device of FIG. 1 inflating a balloon toocclude a blood vessel at a region of interest.

FIG. 4 is a schematic cross-sectional side view of a cowling and distalhousing of a controlled volume inflation-deflation device according toone embodiment.

FIG. 5 is a schematic cross-sectional side view of a cowling and distalhousing of an integrated controlled volume inflation-deflation devicethat performs the initial inflation of a balloon using a pre-determinedinflation volume according to an embodiment.

FIG. 6 is a schematic partial see through side view of an integratedcontrolled volume inflation-deflation device having a latch in amid-latched position that performs the initial inflation of a balloonusing a pre-determined inflation volume.

FIG. 7A is a schematic cross-sectional side view of a cowling and a sideview of a distal housing of an integrated controlled volumeinflation-deflation device that performs the initial inflation of aballoon using a pre-determined inflation pressure.

FIG. 7B is a schematic cross-sectional side view of the cowling and aside view of the distal housing of FIG. 7A, where the cowling isattached to the distal housing in the pre-initial inflation to thepre-determined pressure position.

FIG. 8 is a schematic side view of a retaining pin of an integratedcontrolled volume inflation-deflation device having a recess engaged byan index lock of the proximal housing of the controlled volumeinflation-deflation device that performs the initial inflation of aballoon using a pre-determined inflation volume.

FIG. 9 is a schematic cross-sectional side view of a cowling and distalhousing of an integrated controlled volume inflation-deflation devicehaving a rotational index and recesses along a longitudinal length ofthe inner surface of the cowling corresponding to indexing positions ofthe rotational index that performs the initial inflation of a balloonusing various pre-determined inflation volumes.

FIG. 10 is a schematic side view of one embodiment of an inflationsystem including a partial see through view of an integrated controlledvolume inflation-deflation device that performs the initial inflation ofa balloon using a pre-determined inflation volume attached to anextension tube attached to a stopcock that is attached to a catheterhaving a balloon at its distal end and attached to an aspiration syringefor aspirating the balloon and catheter.

FIG. 11 is a flow diagram of a process to occlude, treat, and perfuse ablood vessel.

FIG. 12 is a schematic side view of one embodiment of an inflationsystem including a partial see through side view of an integratedcontrolled volume inflation-deflation device that performs the initialinflation of a balloon using a pre-determined inflation pressureattached to a catheter having a balloon at its distal end and a view ofthe aspiration syringe.

FIG. 13 is a perspective view of an integrated controlled volumeinflation-deflation device that performs the initial inflation of aballoon using a pre-determined inflation pressure.

FIG. 14 is a schematic side view of one embodiment of an inflationsystem including a partial see through side view of a controlled volumeinflation-deflation device attached to a to a stopcock that is attachedto a catheter having a balloon at its distal end and attached to aconventional low pressure inflation-deflation device that performs theinitial inflation of a balloon using a pre-determined inflationpressure.

FIG. 15 is a cross-sectional side view of an occlusion balloon attachedto a catheter inflated by a minimal volume of fluid (deflated).

FIG. 16 is a schematic cross-sectional side view of the balloon of FIG.15 inflated with a greater volume of fluid.

FIG. 17 is a schematic cross-sectional side view of the balloon of FIG.16 inflated with a greater volume of fluid.

FIG. 18 is a cross-sectional side view of the balloon of FIG. 17inflated with a greater volume of fluid and occluding a blood vessel ata region of interest.

FIG. 19 is a cross-sectional side view of an occlusion balloon attachedto a catheter inflated by a minimal volume of fluid (deflated).

FIG. 20 is a schematic cross-sectional side view of the balloon of FIG.19 inflated with a greater volume of fluid.

FIG. 21 is a schematic cross-sectional side view of the balloon of FIG.20 inflated with a greater volume of fluid.

FIG. 22 is a cross-sectional side view of the balloon of FIG. 21inflated with a greater volume of fluid and occluding a blood vessel ata region of interest.

FIG. 23 is cross-sectional side views of occlusion balloons attached toa catheter inflated by a volume of fluid.

DETAILED DESCRIPTION

Some embodiments are directed to a device for inflating and deflating ablood vessel occlusion device, such as an occlusion balloon, a compliantballoon, an elastic balloon, a non-compliant balloon, and/or a balloonas described below with respect to FIGS. 15-18. Such inflating anddeflating devices may be described by the terms “inflation-deflationdevice” or such as the device known as the “Indeflator®”, which is atrademark of Guidant Corporation, 3200 Lakeside Drive, Santa Clara,Calif. 95054-2807. For example, an inflation-deflation device may have asyringe, which consists of a body and a plunger, for communicating, suchas by pushing and retracting volumes of fluid with the inside orinternal cavity of an occlusion device, such as a balloon, via acatheter or lumen therethrough. Specifically, the syringe may include aconnector at its tip to attach to a proximal end of a tube, cannula, orcatheter having the balloon device attached to it. Theinflation-deflation device may include a plunger or piston within asyringe tube to drive fluid within the syringe tube through the syringetip out the connector through a tube or lumen in the cannula or catheterand into the inside, inner dimension, or cavity of the balloon to expandthe outer diameter of the balloon (e.g., an “occlusion balloon”)sufficiently to occlude a blood vessel at a region of interest.

The outer diameter of an occlusion balloon may be controlled byinflating and deflating the balloon with selected or controlled volumesof relatively incompressible liquids and solutions. For example, acontrolled volume inflation-deflation device may inflate an occlusionballoon with increments of controlled, selected, and/or equal volumes offluid to control the outer diameter of the balloon to predetermined orselected outer diameters that it is known the balloon will reach giventhe initial volume or pressure of fluid injected into the balloon andthe incremental volume increases. Moreover, a controlled volumeinflation-deflation device may include a latch or device having alatched position for placing the plunger at a first location at whichthe volume increments of fluid are forced into the balloon afterinsertion of the balloon on a catheter into a blood vessel to a regionof interest and after the initial inflation of the balloon to an initialOD to effect an occlusion. The controlled volume inflation-deflationdevice latch may also have a deflation latched position to place theplunger at second location to pull a volume of fluid out of the balloonto deflate the balloon and remove the occlusion. Subsequently, thecontrolled volume inflation-deflation device may be transitioned betweenthe inflation latched position and the deflation latched position tore-inflate the balloon to the adjusted OD or deflate the balloon.

The latch may be a releasable latch between a proximal portion, whichconstrains the syringe's plunger via a longitudinal incrementalmanipulation mechanism, and a distal portion, which constrains the bodyof the syringe, so that releasing the latch allows for relative motionbetween the proximal housing and the distal housing, such that theplunger may be moved a distance into or out of the body of the syringe.Specifically the latch may define two releasably latched positions tomove the plunger a set distance within the syringe body. For example,the first position (e.g., an inflation position or an inflation latchedposition) may be used when inflating the balloon with a sufficientvolume to occlude a blood vessel, while the second position (e.g., adeflation position or a deflation latched position) may be used toreduce the volume in (deflate) the balloon sufficiently to allow forperfusion of the blood vessel or the withdrawal or re-positioning of theballoon. Thus, after a proper occlusion volume of fluid inflates theballoon for occlusion, switching or transitioning between thefirst/inflation and second/deflation latched positions allows fortransition between occlusion (balloon inflated) and perfusion (balloondeflated). Specifically, the latch may be releasably latched in thefirst position and the balloon may be inflated with a sufficient volumefor occlusion, then when desired, the latch may be transitioned to thesecond position, reducing the volume of fluid in the balloon so that theblood may perfuse or flow through the vessel and/or the balloon/cathetermay be repositioned. With the latch in the first position, the positionof the syringe plunger may be moved in controlled increments by alongitudinal incremental manipulation mechanism that is a part of theproximal portion of the controlled volume inflation-deflation device.The longitudinal incremental manipulation mechanism allows the operatorto move the syringe plunger in controlled longitudinal increments toforce increments of fluid into the balloon and, thus adjust the diameterof the balloon to effect the desired safe occlusion. In someembodiments, this manipulation mechanism may also include a counter todisplay the number of fluid increments that have been injected into theballoon to adjust its OD. Subsequently, the device may be transitionedbetween the first and second latched positions to rapidly deflate(perfuse the vessel) or rapidly re-inflate (occlude the vessel) theballoon to the previously adjusted OD. The releasable latch will retainthe controlled volume inflation-deflation device in either the first orthe second position when the physician is not transitioning the device(e.g., when the device is not in an unlatched position, such as aposition between the first and second latched positions).

For instance, in the first/inflation latched position, a device may haveor define a selected or non-selected pressure or volume of fluid toinflate a balloon with less than or up to a sufficient amount of fluidso that the balloon can occlude a region of interest of a blood vessel.Alternatively, in the second/deflation latched position, a device mayhave or define a selected or non-selected pressure or volume of fluid,such as to produced a pressure in the balloon that is lower than thepressure applied by the environment to the OD of the balloon (e.g., thesum of blood pressure plus atmospheric pressure at the region ofinterest). In some cases, this pressure may remain low enough during thedeflation that the balloon deflates in a reasonable time (e.g., lessthan twenty seconds).

In at least one embodiment, the design of the controlled volumeinflation-deflation device is modified to allow it to inject fluid intothe balloon until a low predetermined balloon inflation pressure isattained and thus eliminate the need for a conventionalinflation-deflation device. The modified controlled volumeinflation-deflation device may operate compliant balloons or elasticballoons with an ID greater than the OD of the catheter that they aremounted on without another device, a conventional inflation-deflationdevice, to initially inflate the balloon to a given low pressure. Toaccomplish this, a low compliance pressure transducer/pressure gaugethat communicates with the fluid output of the syringe to monitor anddisplay to the operator the balloon inflation pressure is included and aseparate lockable control mechanism, such as a thread mechanism, isprovided to move the syringe body and syringe plunger relative to eachother and force fluid out of the syringe and then allow the controlmechanism to be locked in position. For instance, once thecatheter/balloon has been aspirated, the balloon is positioned at theregion of interest for occlusion and the modified controlled volumeinflation-deflation device has been filled with fluid and de-bubbled inits first (inflation) position, the modified controlled volumeinflation-deflation device is connected to the balloon inflation lumenof the catheter. The separate lockable control mechanism is thenunlocked and adjusted until the desired initial balloon inflationpressure is attained and then the separate lockable control mechanism islocked in position, preventing any unintended further control mechanismadjustment. The position of the syringe plunger may then be moved incontrolled increments by the longitudinal incremental manipulationmechanism to adjust the OD of the balloon to attain vessel occlusion.The modified controlled volume inflation-deflation device may then betransitioned from the first (inflation) latched position to the second(deflation) latched position to deflate the balloon and allow perfusionand/or catheter/balloon repositioning. Subsequently, the device may betransitioned between the first and second latched positions to rapidlydeflate (perfuse the vessel/reposition the catheter/balloon) or rapidlyre-inflate (occlude/treat the vessel) the balloon to the previouslyadjusted OD.

In at least one embodiment, the design of the controlled volumeinflation-deflation device is modified in another manner to allow it toinject a designed/controlled amount of fluid into the balloon and thuseliminate the need for a small volume syringe. The modified controlledvolume inflation-deflation device may operate compliant or elasticballoons without another device, a small volume syringe or syringe-likedevice, to initially inflate the balloon to a given volume. Toaccomplish this, the releasable latch may be designed to define amid-latched position(s) between the first latched position and thesecond latched position corresponding to volume(s) of fluid forinflating the balloon(s) to a nominal OD, a minimum OD, a desired OD, toa desired volume or low pressure when the controlled volumeinflation-deflation device is transitioned from the mid-latchedposition(s) to the first latched (inflation) position. For instance, themodified controlled volume inflation-deflation device may be set to amid-latched position prior to its attachment to the aspirated catheter(and balloon). When the balloon is at the region of interest, themodified controlled volume inflation-deflation device is connected tothe catheter lumen that communicates with the balloon and then themodified controlled volume inflation-deflation device is transitionedfrom the mid-latched position to the first latched position to push avolume of fluid into the balloon to inflate it to its initial or nominaldiameter or a low pressure. Then the longitudinal incrementalmanipulation mechanism is adjusted by the physician to move thesyringe's plunger in controlled increments to force increments of fluidinto the balloon and, thus adjust the diameter of the balloon to effectthe desired safe occlusion. The occlusion may be maintained duringtreatment, and then the controlled volume inflation-deflation device maybe transitioned to the second latched position to allow perfusion of thevessel. Since the occlusion volume was previously pushed into theballoon with the modified controlled volume inflation-deflation devicein the first latched position, transitioning the controlled volumeinflation-deflation device from the second latched position to the firstlatched position, after a desired perfusion duration, pushes theocclusion volume back into the balloon and re-occludes the blood vessel.Thus, the modified controlled volume inflation-deflation device may betransitioned between its first latched and second latched positions toocclude the blood vessel for treatment when in the first latchedposition, and to perfuse the blood vessel in between treatments when inthe second latched position.

To accommodate various sizes and types of balloons, at least oneembodiment of the controlled volume inflation-deflation device may havevarious mid-latch positions corresponding to the various balloons toinflate the balloons with various volumes of fluid to attain the desiredinitial degree of balloon inflation or balloon OD once the balloon is atthe desired location in a vessel. A controlled volumeinflation-deflation device that is modified to perform the initialinflation of a balloon to a desired initial OD, initial inflation volumeand/or initial inflation pressure may be termed an “integrated”controlled volume inflation-deflation device.

In at least one embodiment, a stopcock may be used to attach anaspiration syringe between the controlled volume inflation-deflationdevice and a catheter having a balloon positioned at a region ofinterest in a blood vessel. The stopcock may be adjusted to prohibitflow between the controlled volume inflation-deflation device and thecatheter while the aspiration syringe is used to aspirate air from thecatheter and balloon (and replace it with inflation fluid). Afteraspiration of the catheter and balloon, the stopcock may be adjusted toprohibit flow between the aspiration syringe and the catheter, but allowflow between the controlled volume inflation-deflation device and theballoon (i.e. via a catheter lumen). The aspiration syringe may then beremoved from the stopcock. Subsequently, the balloon may be inflated forocclusion and deflated for perfusion by the controlled volumeinflation-deflation device as previously described.

Moreover, some embodiments include a flexible extension line connectedto the controlled volume inflation-deflation device's syringe fluidoutput and terminating in a male Luer or, preferably, a rotating maleLuer. Alternately, the extension line may incorporate other connectorsand/or be a separate device that is connected to the ballooninflation/deflation system in various locations. The extension linecontains a flexible tube, but, unlike conventional extension lines andthe extension lines incorporated into conventional inflation-deflationdevices, this tube does not appreciably change its internal volume inresponse to bending or to pressure changes within its ID (it has a lowcompliance). Thus, this extension line does not introduce volume changesor volume change variability of a magnitude that materially interfereswith the control of the balloon's OD by the controlled volumeinflation-deflation device. To produce these desired properties, theextension line tubing may be comprised of an inner material with amodulus greater than a modulus of an outer material that is formedaround the inner material. In addition, if the inner material and outermaterial are miscible, then the inner and outer material may beco-extruded to form the extension line tube. Alternately, the innermaterial and outer material may not be miscible, but are held togetherby a third co-extruded material, an adhesive polymer. In addition, theinner material may form a relatively (compared to conventional extensionline tubes incorporated into conventional inflation-deflation devicesand conventional extension lines) small ID tube with a relatively thinwall. In addition, the outer material may form a conventional extensionline tube OD that facilitates the extension line's handling, resistanceto kinking and attachments to connectors or other devices.

In some embodiments, the controlled volume inflation-deflation device isintended to be used to inflate balloons of different initial OD's. Insuch a case, it is desirable that the incremental increase of theballoons' OD's in response to equal volume inflation increments besimilar to each other or otherwise controlled. One reason that this isdesirable, is to allow or select the incremental increase in a balloon'sOD to be less than or equal to the maximum over-stretch, beyond thatrequired for occlusion, that a vessel may be subjected to by theballoon. According to some embodiments, the reasoning goes like this: Insome cases, a physician may inflate the balloon very close to obtainingthe desired occlusion, but is not satisfied with the occlusion. Thephysician may then go to the next inflation increment, whichincrementally increases the balloon's diameter and occludes the vesselsatisfactorily. Since the maximum that the balloon OD could grow is theincremental increase in the balloon's diameter, the maximum that thevessel could be stretched beyond that necessary for the desiredocclusion is just less than that OD increment. A certain amount orpercent diameter change of possible vessel over-stretch is safe and willnot cause a dissection and/or a significant stenosis or re-stenosisvessel reaction. This amount may be considered to set or select themaximum OD increment for each balloon. The number of OD incrementsrequired to cover the desired OD range of a balloon sets the totalincremental injection volume required. One way to make the incrementalincrease of the balloons' OD's in response to equal volume inflationincrements similar to each other or otherwise controlled relative toeach other, is to adjust the length of the various balloons. Forballoons with a similar initial configuration/shape, this adjustment issuch that a balloon with a smaller initial OD has a longer length than aballoon with a larger initial OD.

Additionally, an occlusion device or balloon that has an initial ornominal diameter that requires an initial volume of fluid to be injectedinto the balloon to inflate it such that the folds of the balloon areremoved and/or it assumes an initial shape or OD is disclosed having anouter diameter that increases by relatively (compared to other balloonshapes) equal increments in diameter increase in response to beinginflated by equal increments in volume over a range of diameters. Forexample, the balloon may have a cross-sectional profile or a contourthat includes tapered (conical) ends extending proximally and distallyto a cannula to which they are attached and includes a center portionbetween the tapered ends that defines a cylindrical shape. Other morecurved balloon shapes (i.e. elliptical, spherical), have a more rapiddecrease in their diameter increase increment per inflation volumeincrement as their diameter increases. Having relatively equal or moreequal increments in diameter increase in response to being inflated byequal increments in volume over a range of diameters is desirablebecause this also minimizes the number of required inflation increments.

For example, FIG. 1A is a schematic partial see through side view of acontrolled volume inflation-deflation device having a latch in the first(inflation) latched position. FIG. 1A shows the controlled volumeinflation-deflation device 100 having proximal end 106 and distal end104. Controlled volume inflation-deflation device 100 also has knob 130rotationally attached to proximal housing 140 which is positionedrelative (e.g., attached or coupled) to distal housing 120 by releasablelatch 150. Distal housing 120 is attached to syringe tube 112 havingplunger 110 disposed therewithin and tip 113. FIG. 1A also showsretaining pins 160 and 162 attached to distal housing 120 and extendingwithin proximal housing 140.

Knob 130 is shown coupled to proximal housing 140 and to screw mechanism170. Coupled between knob 130 and screw mechanism 170 is a countermechanism (not shown) that causes a display that is visible throughcounter window 141 to increment (or decrement) in response to therotation of knob 130. It is contemplated that screw mechanism 170 may becoupled to knob 130 such that rotation of knob 130 rotates screwmechanism 170 to engage plunger holder 172. For example, screw mechanism170 engages plunger holder 172 in a threaded fashion so that plungerholder 172 may move or translate between the distal and proximal end ofscrew mechanism 170 when screw mechanism 170 is rotated by knob 130.Hence, plunger holder 172 may have threads (e.g., a set of threads or athreaded surface) corresponding to those (e.g., a matching set ofthreads or a threaded surface to engage the threads of holder 172) ofscrew mechanism 170. It is considered that screw mechanism 170 oranother screw mechanism mentioned herein may include various gears,shafts, threaded assemblies, devices, surface, nuts, bolts, screws,receptacles, or other devices or surfaces having a set of threads, asknown in the art, other than those shown for holder 172 and mechanism170. Specifically, a screw mechanism may include a first set of threadscoupled or attached to a syringe tube, such as to couple the syringetube to a distal housing; and/or a second set of threads (e.g., a secondset of threads that match the first set of threads to engage the firstset of threads) coupled or attached to a plunger, such as to couple theplunger to a proximal housing. In turn, plunger holder 172 is attachedto shaft 174 which is attached to plunger 110. Thus, rotation of knob130 in rotational directions ROTS will cause plunger holder 172 to pushor pull shaft 174 which in turn will push or pull plunger 110 alonglength L within syringe tube 112.

Plunger 110 may form a seal with the inner wall of syringe tube 112,such as a gas, air, water, liquid, and/or fluid-resistant seal thatallows plunger 110 to push, retract, or withdraw a volume of fluidwithin syringe tube 112 and keeps the system closed, such that air isnot appreciably drawn past the seal into the VOL 1 of syringe tube 112during balloon deflation and neither air nor fluid is appreciably pushedpast the seal and out of VOL 1 during balloon inflation. For example,volume of fluid VOL1 is shown distal to plunger 110 in syringe tube 112,and thus may be pushed out of tip 113 of syringe tube 112 by plunger 110if plunger 110 is moved further along length L towards distal end 104,such as by rotating knob 130 in the proper direction of rotationaldirections ROTS. In some embodiments, syringe tube 112 may be a 1milliliter (ml) syringe and tip 113 may be a Luer lock tip.

Window 141 may be a window to display indicia such as numbers indicatingthe position of plunger 110 within syringe tube 112. For example, window141 may display the number “0” when knob 130 is rotated to a minimumposition so that the plunger is at the closest position to proximal end106 of the controlled volume inflation-deflation device adjustable byknob 130. Rotation of knob 130 may increment through a number ofpositions between 2 and 100 positions, such as by rotating forward andbackward in directions ROTS between 10, 15, 18, 20, 22, 25, or 30positions (having a very large number of positions is not convenient forthe user). For example, where knob 130 rotates through 20 positions,window 141 may show the number “20” when knob 130 is rotated to pushplunger at the position closest to distal end 104 allowed by thecontrolled volume inflation-deflation device by rotating knob 130 (e.g.,window 141 transitions between the number “0” position and thesubsequent 20 positions until it reaches the number “20” position). Alsoconsidered are a wide variety of counter/inflation status indicators ormechanisms, such as electronic displays like LED or LCD displays. Inaddition, there may be more than one window 141 disposed over thecircumference of the proximal housing 140 to allow the count to be read,regardless of the rotational orientation of the controlled volumeinflation-deflation device 100. Alternatively, window 141 and anycounter mechanism may be eliminated and a user may rely on counting theclicks/detents, observing a pressure change in the vessel distal to theballoon or other occlusion indicator while turning knob 130 to effectthe movement of plunger 110 within syringe tube 112 to effect a desiredocclusion or balloon OD.

Releasable latch 150 may include structures and mechanisms to releasablylock proximal housing 140 at different latch positions with respect todistal housing 120 in order to locate plunger 110 at different locationsalong length L. For example, releasable latch 150 may allow proximalhousing 140 to be latched at positions closer towards distal end 104 orcloser towards proximal end 106 of inflation-deflation device 100 withrespect to the position or location of distal housing 120 to move,progress, advance, translate, or slide plunger 110 along length L toadjust an amount of fluid (e.g., such as volume VOL1) within syringetube 112. As shown in FIG. 1A, latch 150 may define or be in aninflation latched (first) position INFLAT to removably lock latch 150 tolocate plunger 110 at location L1 along length L. In addition, latch 150may define a deflation latched (second) position to removably lock thelatch to locate plunger 110 at a different location proximal to locationL1 along lines L.

Latch 150 may be transitioned between a inflation latched position, adeflation latched position, and/or other latched positions (e.g., suchas a mid-latched position described further below with respect to FIGS.5, 6 and 8-10) by grasping distal housing 120 and proximal housing 140(e.g., with one human hand each) and pulling the housings apart orpushing them together until latch 150 engages into a inflation latched,deflation latched, or other latched position. Latch 150 may be describedas being in an unlatched position when not in an inflation latched,deflation latched, or other latched position. Thus, once in a latchedposition, latch 150 may be held (e.g., locked) in that position with asufficient force to hold a volume of fluid in a balloon withoutsnapping, popping, slipping, or otherwise becoming unlocked or unlatchedfrom that releasably locked position without manipulation, such as by ahuman hand, a robotic part, a tool, or an instrument. Moreover, latch150 may hold that latched or locked position while knob 130 is rotatedto increase and decrease the volume of fluid in syringe tube 112, suchas is described further below. Locating, transitioning, holding,latching, or locking a latch referred to herein (e.g., latch 150) may bedescribed as positioning a proximal housing (e.g., housing 140) relativeto a distal housing (e.g., housing 120).

Furthermore, in some embodiments, knob 130 may have indexing locks 132and 134 to engage recesses 142 and 144 of proximal housing 140. Indexinglocks 132 and 134 may be releasable locks, devices, keepers, or detentsto engage or mate with recesses 142 and 144. In turn, recesses 142 and144 may be depressions, receptacles, notches, detents, or holes in asurface of proximal housing 140 adjacent to knob 130 having a dimensionsuitable to restrain indexing locks 132 and 134 from snapping, slipping,popping, or otherwise transitioning out of recesses 142 and 144 wheninflation-deflation device 100 is in operation, inflating an occlusiondevice to occlude a blood vessel, perfusing a blood vessel, or otherwiseoperating as described herein. Thus, rotating knob 130 in rotationaldirections ROTS, such as by a human hand, may cause indexing locks 132to disengage, or transition out of recesses 142 and 144 so that knob 130will rotate and plunger 110 can be moved along length L. But, once knob130 is rotated to a desired orientation or rotational position andindexing locks 132 and 134 engage recesses 142 and 144, knob 130 andplunger 110 will be locked in that position until knob 130 is againrotated by the hand. For example, indexing locks 132 and 134, andrecesses 142 and 144 may be oriented so that they are engaged when knob130 is rotated to lock plunger 110 at various locations along length Lthat are equidistant from one another, such as to push or withdraw equalvolumes of fluid from syringe tube 112 via tip 113.

For example, FIG. 1B is a schematic cross-sectional side view of aportion of the controlled volume inflation-deflation device showing anindexing lock engaging a recess. FIG. 1B shows indexing lock 132 havingball B and spring S in receptacle R within knob 130. Spring S biasesball B toward recess 142. Receptacle R accommodates the spring andretains the ball B such that ball B may only protrude a limited distanceout of receptacle R. It is contemplated that recesses described hereinsuch as recess 142 may define various shapes with respect to the surfacethat they are formed in and may define various cross-sectional shapes orprofiles with respect to the surface they are formed in sufficient to beengaged by indexing locks as described herein. For example, a recess maydefine a groove extending radial around the inner surface of a cowling,such as cowling 180 instead of defining a single hole or radial positionas is explained further below with respect to recess 482 of FIG. 4. Itis also contemplated that the positions of an indexing lock(s) andengaging recess(es) may be reversed. For example, indexing lock 132 maybe mounted in proximal housing 140 and recess 142 in knob 130.

FIG. 1B shows ball B, and recess 142 having beveled sidewalls BV1 andBV2 in proximal housing 140. Ball B is shown engaging (e.g., such as bytouching and/or being restrained from moving farther in the directionof) sidewall BV1 in proximal housing 140. It can be appreciated thatball B may engage other portions of recess 142, such as by engagingbeveled sidewall BV2, or another sidewall of recess 142 in proximalhousing 140. Beveled sidewalls BV1 and BV2 may be the same beveledsidewall, such as where recess 142 defines a circular, oval, or othercurved shape with respect to the surface of proximal housing 140.Alternatively, beveled sidewall BV1 and BV2 may be sidewalls of two ormore separate sidewalls, such as where recess 142 defines a triangular,or trapezoidal shape. Alternatively, recess 142 may have a perpendicularsidewall or sidewalls. Thus, ball B may engage recess 142 withsufficient force from spring S to prohibit or preclude ball B fromslipping, snapping, or popping out of the recess until knob 130 isforcibly rotated, such as by a hand of a person, at which point ball Bmay pop, slip, or snap out of recess 142. Additionally, ball B mayengage the sidewalls or surface OD of recess 142 such that the positionof ball B, and thus the position of knob 130 relative to proximalhousing 140, is held with little or no position variation.

Moreover, the releasable latch can include a cowling attached to aproximal end of the distal housing and having an inner surface extendingover an exterior surface of the proximal housing with at least onecowling recess in the inner surface and at least one indexing lock atthe exterior surface of the proximal housing to engage the cowlingrecesses. It can be appreciated that the concept of indexing locksincludes devices for which only one lock/recess is required foroperation of the releasable latch. It may be preferred that there be 2or more index locks of the ball or round nose spring plunger type tobalance forces and reduce friction at opposite ends of a rotational orlongitudinal axis of inflation-deflation device.

Also, there may be indexing locks that comprise just a spring. Forinstance, FIG. 1E shows radial spring or o-ring 299 in groove 298. FIG.1E also shows undeformed radial spring cross-section 297, and deformedradial spring cross-section 298. The radial spring can be canted so thespring will be more easily deformed when subjected to radial forces andthe two ends of the spring are attached to each other to form a loop inapplications like that of the proximal and distal housings (in a knobapplication the springs could be straight, not looped). The spring loopcan go in one groove of one part, usually in a stretched (extended)condition, that retains it and it engages another groove in a secondpart and forms the releasable latching mechanism. In other words, thisone spring can act like a lot of individual ball nosed plungers. In someembodiments, even an o-ring (usually lubricated) will operate in thisconfiguration to make a releasable latch mechanism that is useful forcreating the inflation and deflation latched (and mid-latched) positionswith the proximal and distal housings. In cases with a radial spring oro-ring, there is may be only one indexing lock, the radial spring or theo-ring.

According to some embodiments, the indexing locks may include ball orround nose spring plungers, and the recesses may be through holes orblind holes having one of straight sidewalls and beveled sidewalls. Insome cases for the knob recesses that operate with ball or round nosespring plungers, preferred embodiment may have straight sidewalls.Embodiments contemplated also include the simplest to design andconstruct and that provide the easiest means to control the forcesapplied by the spherical ends of an indexing lock (ball or round nosespring plungers) to the knob. Also, recesses described herein may havestraight sidewalls (e.g., see Figure below). It is also worth notingthat in any instance described herein of an indexing lock and recess (orgroove), the structure or location of the indexing lock and recess (orgroove) may be reversed, where possible.

In some embodiments the indexing lock is a ball nose spring plunger, around nose spring plunger, a radial spring, or an o-ring. Also, thecowling recess may be a hole in the cowling, a blind hole in the innersurface of the cowling, such holes with beveled and/or straightsidewalls, or a beveled and/or straight sided groove extending radiallyaround the inner surface of the cowling with respect to a longitudinalaxis of the proximal housing. For more specific descriptions of acowling recess, see FIG. 9 below.

It can be appreciated that the structure described for FIG. 1B may alsoapply to indexing lock 134 and recess 144. It is also contemplated thatindexing lock 132 and other indexing locks as described herein may beball nose springs, round-nose spring plungers, ball-nose springplungers, or other spring actuated structures providing sufficientengaging force with/to a detent, ratchet-like or recess as describedherein (e.g., recess 142). The structure described above with respect toFIG. 1B may apply to various other indexing locks, detents, and recessesof controlled volume inflation-deflation devices as described herein.Moreover, it is considered that index lock 132 and other indexing locksand corresponding recesses as described herein maybe or include otherreleasable locking or latching mechanisms such as those magnetically,electrically, mechanically, pneumatically, hydraulically, or otherwisereleasably locked or latched with sufficient force as described herein

In some cases, the indexing locks and recesses of knob 130 and proximalhousing 140 may be replaced with a friction lock (e.g., a spring forcinga portion of surfaces of knob 130 and housing 140 against each other) orother locking/position retaining mechanism to omit indexing knob 130 atspecific rotational locations or positions, such as to remove oreliminate the incremental nature of the volume of fluid pushed orretracted by controlled volume inflation-deflation device 100.

FIG. 1A also shows cowling 180 attached to a proximal end of distalhousing 120, extending over an exterior surface of the distal end ofproximal housing 140 and having stop 190. Cowling 180 has recesses 182and 184 along its inner surface, ISUR. Recesses in cowling 180 or othercowlings herein may be described as cowling recesses or cowling grooves.Proximal housing 140 is shown having indexing locks 152 and 154 to movealong the inner surface of cowling 180 for engaging recesses 182 and184. In this engagement however, the indexing locks 152 and 154 engagethe proximal sides of recesses 182 and 184, such that a force isgenerated the forces proximal housing 140 up against stop 190. Thus,proximal housing 140 may be moved in directions DIR with respect tocowling 180 and distal housing 120 so that indexing locks 152 and 154move along inner surface ISUR of cowling 180. When indexing lock 152 and154 begin to engage recesses 182 and 184, a force is generated thatpulls the proximal housing 140 up against stop 190, such that controlledvolume inflation-deflation device 100 may be positively held in theinflation latched position INFLAT, as shown in FIG. 1A. For instance,when distal housing 120 and proximal housing 140 are pushed together,such as by each being grasped in a human hand and forced together, stop190 may prohibit the distal end of proximal housing 140 from movingfurther towards the proximal portion of distal housing 120 so that locks152 and 154 are at least partially engaged with recesses 182 and 184 andprovide a sufficient force to retain proximal housing 140 pressedagainst stop 190. As such, stop 190 may function as a repeatable andpositive inflation latched position INFLAT, such as is described furtherbelow with respect to stop 490 and FIG. 4.

According to some embodiments, a stop (e.g., stop 190) may be used in aninflation-deflation device to control/set the force (holding force) thatpushes the distal and proximal housings together in the first(inflation) latched position, such that this position is constantly andreliably exactly held. By having the index lock(s) engage one side ofthe recess(es) or groove at a controlled location as held by aninterference with a stop, the holding force generated by the force ofthe indexing lock(s) pushing up against the side of the recess(es) orgroove can be calculated and controlled. Without this holding forcebeing large enough, the pressure inside the syringe (e.g., generatedduring balloon inflation) can create a force between the plunger andsyringe tube that will overcome the holding force and cause the distaland proximal housings to move apart. This movement may be undesired asit can reduce the amount of fluid injected into the balloon during theinflation operations, making balloon OD less, less certain, lesscontrollable and/or making it possible (in an extreme case) for thedevice to move out of the first (inflation) latched positionspontaneously. The amount of holding force, pressure inside the syringeexpected during use, available shapes, sizes, and devices used forindexing locks and recesses are factors to be considered during designof the latch, first position, inflation position, and/or engagement ofthe indexing lock and the groove or recess to produce a holding force(or having any mechanism to produce this holding force).

Indexing locks 152 and 154 retained or removably locked and engagedwithin recesses 182 and 184 may define an inflation latched position. Atthis inflation latched position, device 100 may inflate a balloon usingknob 130, as previously described. As the balloon's OD is adjusted, thepressure in the balloon will increase. The pressure will be felt in thesyringe and apply a force between the syringe tube 112 and plunger 110,which will be applied to the proximal housing 140 and stop 190 in amanner which will tend to cause them to separate. However, the forceapplied by the engagement of the indexing locks 152 and 154 withrecesses 182 and 184 exceeds the forces applied by the syringe tube 112and plunger 110. Thus, device 100 remains positively locked in theinflation latched position INFLAT (proximal housing 140 up against stop190) during balloon inflation to an occlusive OD.

FIG. 11C is schematic side views and cross-sectional side views ofvarious components of a controlled volume inflation-deflation device.FIG. 1C shows various components of controlled volumeinflation-deflation device 200 disassembled, where inflation-deflationdevice 200 and/or various components thereof may be similar toinflation-deflation device 100 and various components thereof. Forexample, inflation-deflation device 200 includes knob 230, proximalhousing 240, screw mechanism 270, plunger holder 272, syringe tube 212,cowling 280, and distal housing 220.

Knob 230 is shown having grooves, such as groove 231 along its outerperimeter to aid in gripping during rotation, and indexing locks 232,234 and 236 along a surface to be oriented towards proximal housing 240.In other embodiments, the knob may have other means to aid gripping,such as raised and/or textured portions. Knob 230 may be a knob similarto knob 130, and locks 232, 234 and 236 may be locks similar to locks132 and 134 of FIG. 1A. Knob 230 may be attached to screw mechanism 270along line 268. For example, a shaft may be disposed within a socket ofknob 230 and of screw mechanism 270 where indicated by line 268. Knob230 may engage proximal housing 240 and screw mechanism 270 may bedisposed within distal housing 240. The longitudinal position of screwmechanism 270 is fixed relative to the proximal housing 240 by pins (notshown) that penetrate the proximal housing 240 and engage the groove inthe screw mechanism 270, such that screw mechanism 270 may be rotated bythe rotational action of knob 230. Thus, locks 232, 234 and 236 mayengage recesses 242, 244 and 246 of housing 240. FIG. 1C shows recesses242, 244, and 246 with straight sidewalls. However, as noted above forrecess 142, other shapes may be used, as described above for FIG. 1A.Proximal housing 240 is also shown having window 241. Window 241 may bea window similar to window 141 of FIG. 1A. Specifically, various gears,wheels, axles, shafts, and/or other mechanical structure may existbetween knob 230 and screw mechanism 270 to display indicia at window241 as a result of rotation of knob 230 and/or movement of plunger 210,such as is described with respect to window 141 of FIG. 1A.

FIG. 1C also shows plunger holder 272 and syringe tube 212 which may bedisposed within cowling 280 and distal housing 220. Syringe end 215 maybe disposed or held within cavity 285 of cowling 280 or distal housing220, such as by pushing syringe tube 212 through distal housing 220 suchthat end 215 rested within cavity 285, as indicated by line 288, andfixing a suitable retaining ring or cap (not shown) over it in thecavity behind cavity 285.

Plunger holder 272 includes threads 273 such as for engaging threads 271of screw mechanism 270. Specifically, threads 271 and 273 may be both“left hand” threads or both “right hand” threads. As shown, left handthreads would be chosen to cause the clockwise rotation of the knob 230(when viewing the knob 230 from a proximal location) to result in thedistal movement of the plunger 210 and, thus an increase in theballoon's OD, as will subsequently be described. Such a clockwise motionbeing the rotational motion that increases a balloon's diameter is thestandard configuration of inflation-deflation devices. Holder 272 isshown having a slot or cavity 275 for engaging or holding plunger end276, such as if end 276 were placed or fixed in cavity 275 (e.g., seeline 278). Holder 272 engages features (not shown) on the ID of proximalhousing 240 that prevent its rotation and thus, allows knob 230 rotationand thus screw mechanism 270 rotation to result in the proximal ordistal translation of plunger end 276. The engagement of holder 272 withscrew mechanism 270 and proximal housing 240 may limit its translation,such that the maximum volume of fluid that may be expelled into, forinstance, a balloon inflation lumen is controlled. By controlling thismaximum volume, the maximum possible volume incremented OD of theocclusion balloon is controlled to within safe limits (e.g., to preventballoon bursting) by the controlled volume inflation-deflation device200 or 100. Plunger end 276 is attached to plunger 210 via shaft 274.Shaft 274 may correspond to shaft 174, syringe tube 212 may correspondto syringe tube 112, plunger 210 may correspond to plunger 110, and tip213 may correspond to tip 113 of FIG. 1A.

FIG. 1C shows cowling 280 including proximal end 255 and recess 282along its inner surface, inner surface ISUR. Recess 282 may be a recessincluding recess 182 and 184 of FIG. 1A. Locks 252 and 254 of proximalhousing 240 may engage an inner surface and recesses or grooves ofcowling 280 similar to how locks 152 and 154 engage inner surface ISURand recesses 182 and 184 of FIG. 1A. Not shown on proximal housing 240is a third lock, where locks 252, 254 and the not shown lock arepositioned at equal intervals around the OD of the proximal housing 240.Thus, the locks 252, 254 and the not shown lock hold the proximalhousing 240 roughly centered inside the cowling 280 due to theirengagement forces with the inner surface ISUR of the cowling 280. Thisprovides for a smooth transitioning between the inflation latched anddeflation latched positions. Moreover, recess 282 may be a grooveextending radially around the inner surface ISUR, such as a groovehaving beveled sidewalls as described above with respect to BV1 of FIG.1B. It is contemplated that recess 282 may be a groove having variousother cross-sectional profiles to be engaged by indexing locks 252 and254. As shown, recess 282 has a vertical sidewall that, when in theinflation latched position, engages the locks in a manner that creates aforce that presses the distal end of proximal housing 240 into the stop290 (surface) of the distal housing 220. Although FIG. 1C shows recess282 with straight sidewalls, other shapes may be used, as describedabove for FIG. 1A. Thus, when indexing locks 252 and 254 engage recess282, controlled volume inflation-deflation device 200 may be held orreleasably latched in an inflation latched position (e.g., positionINFLAT as shown in FIG. 1A), and when the indexing locks engage proximalend 255, inflation-deflation device 200 may be held or releasablylatched in a deflation latched position (e.g., such as position DEFLATof FIG. 2 shown below).

Cowling 280 also includes stop 290, such as stop 190 described above forFIG. 1A. Next, FIG. 1C shows distal housing 220 which may be a distalhousing similar to distal housing 120 described above for FIG. 1A. Thus,distal housing 220 and cowling 280 may be a single component or becomponents attached by threaded or indexing structures such as describedfurther below for FIGS. 7 and 9

FIG. 1D is a sectional view of knob 230 along perspective A of FIG. 1C.FIG. 1D shows knob 230 having indexing locks 232, 234, and 236. FIG. 1Dalso shows socket 238, such as a socket into which a shaft may bedisposed to attach knob 230 to screw mechanism 270 along line 268 asshown in FIG. 1C. Specifically, proximal housing 240 may include one ormore recesses for engaging locks 232 through 236. It is possible thatproximal housing 240 include sufficient recesses, such that all locksengage a recess in a similar manner at each increment of rotation of theknob. This balances the forces between the knob and the proximalhousing, and minimizes any bending moment that may be applied to anyshaft or other mechanism that may be disposed along line 268 tofacilitate the smooth operation of the knob, the smooth translation ofthe plunger and smooth operation any display indicia mechanism.

FIG. 1D shows indexing locks 232 through 236 in a triangular orientation120 degrees from each other with respect to socket 238. Indexing locks232 through 236 may each be an indexing lock similar to indexing lock132 as described above. Although FIG. 1D shows three indexing locks,more or less than three indexing locks may be used to provide sufficientfunctionality to releasably latch knob 230 in equal a rotationalincrement positions with respect to proximal housing 240. Alternately,the indexing of knob may be accomplished by the functionality of thevarious gears, wheels, axles, shafts, and/or other mechanical structure(not shown) that may exist between the knob and the screw mechanism,which may also function to display indicia at the window as a result ofrotation of knob.

Knob 230 is shown having a circular or cylindrical cross-sectional shapewhen viewed along or with respect to perspective A. It is contemplatedthat the other components of inflation-deflation device 200 or otherinflation-deflation devices mentioned herein may include a circular orcylindrical shape similar to that shown by the view of knob 230 withrespect to perspective A. Specifically, proximal housing 240, screwmechanism 270, plunger holder 272, syringe tube 212 and componentsthereof, cowling 280, and distal housing 220 may also have a circular orcylindrical shape with respect to perspective A. Moreover, correspondingcomponents or features to those described above for inflation-deflationdevice 200, inflation-deflation device 100, or inflation-deflationdevice 1010, 1310, and 1410, or an inflation-deflation device includingstructure 400, 500, 700, 800, or 900 described below, may have acircular or cylindrical shape with respect to perspective A. Finally, itis contemplated that the knob, proximal housing, screw mechanism,plunger holder, syringe tube and components thereof, cowling, and/ordistal housing of inflation-deflation devices described herein may havevarious other appropriate shapes with respect to perspective A, such aswhere one or more components have a triangular, oval, square, oblong,and/or polyhedral shape with respect to perspective A.

When index locks 152 and 154 are not in recesses 182 and 184 (see FIG.1A) or when locks 252 and 254 are not in recess 282 (see FIG. 1C), theindex locks may be releasably locked or latched to another position,such as a deflation latched position. For example, FIG. 2 is a schematicpartial see through side view of the controlled volumeinflation-deflation device 100 of FIG. 1A having the latch in a second(deflation) latched position. FIG. 2 shows controlled volumeinflation-deflation device 100 in deflation latched position DEFLAT. Inposition DEFLAT, proximal housing 140 is disposed proximally or towardsproximal end 106 with respect to the position of cowling 180 and distalhousing 120. For example, proximal housing 140 and distal housing 120may be grasped and pulled or forced apart by human hands.

As shown in FIG. 2, gap 189 exists under cowling 180 between the distalend of proximal housing 140 and stop 190. Since plunger holder 172 isattached to plunger 110 via shaft 174, plunger 110 is withdraw orretracted to location L2 when inflation-deflation device 100 istransitioned to position DEFLAT. Thus, when moved from position INFLATto position DEFLAT, controlled volume inflation-deflation device 100 maywithdraw or retract a volume of fluid through tip 113. Specifically,volume VOL2 of fluid in syringe tube 112 as shown in FIG. 2 is greaterthan volume VOL1 as shown in FIG. 1A. Moreover, the difference betweenvolumes VOL2 and VOL1 may be selected or controlled by selecting orcontrolling the lengths of cowling 180 and pins 160 and 162 and thelocations of recesses 182 and 184, stop 190 and stop surfaces 163 and162 (to define position INFLAT and select/retain volume VOL1 and todefine position DEFLAT and select/retain VOL2). This change in volumemay be selected to be greater than the fluid volume in an inflatedballoon and, thus will reliably deflate the balloon if the inflatedballoon is connected to the controlled volume inflation-deflation device100 in the position INFLAT and then the controlled volumeinflation-deflation device 100 is transitioned to the position DEFLAT.For example, as shown in FIG. 2, latch 150 defines deflation latchedposition DEFLAT to removably lock latch 150 to locate plunger 110 atlocation L2 along length L, such as by indexing locks 152 and 154 beingretained or removably locked proximally beyond or behind proximal end155 of cowling 180 (to select/retain volume VOL2). Thus, indexing locks152 and 154 may engage the back end, edge or back surface of cowling 180at proximal end 155 with sufficient force such as not to slip, snap, orpop towards distal end 104, such as is described above with respect toindex lock 132 and recess 142 with respect to FIG. 1A and FIG. 1B.

Note that retaining pins may be oriented opposite pins 160 and 162(e.g., with the attachment and stop housings reversed). Specifically,one or more retaining pin can be attached to the proximal housing andextending through a portion of the distal housing, each retaining pinincluding a stop surface to engage a surface of the distal housing tolimit a distance the proximal and distal housings can move apart and/orprevent rotation of the distal housing relative to the proximal housing.Moreover, in some embodiment retaining pins may be attached to thecowling and extending through a portion of the distal housing or theproximal housing to engage a stop surface of the distal housing or theproximal housing.

In addition, while or when inflation-deflation device 100 is in positionDEFLAT, proximal housing 140 and distal housing 120 may be restrained orprohibited from separating too far in directions DIR. Specifically, insome cases, proximal housing 140 and distal housing 120 may berestrained or prohibited from separating too far away from each other,such as by being prohibited from separating proximally more thannecessary for indexing locks 152 and 154 to move proximally beyond orbehind proximal end 155. In addition, it can be appreciated that suchrestraint may include prohibiting separation sufficient to withdrawplunger 110 from within syringe tube 112 and to be a part of themechanism that defines VOL2. For example, FIGS. 1A and 2 show retainingpins 160 and 162 that may be used for such restraint. As shown in FIG.2, retaining pin 160 includes threads 166, such as for attachingretaining pin 160 to distal housing 120. Similarly, retaining pin 162includes threads 167, which may be used for the same purpose. Inaddition, retaining pin 160 includes stop surface 163, such as a surfacefor engaging a surface or structure of proximal housing 140 to prohibitproximal housing 140 from extending too far away from distal housing120, as described above. Similarly, retaining pin 162 includes stopsurface 165, which may be for the same purpose as stop surface 163.Retaining pins 160 and 162 may be threaded rods, and/or structure asshown and described below with respect to pin 860 of FIG. 8.Additionally, retaining pins 160 and 162 engage the distal housing 120and the proximal housing 140 in a manner that prevents them fromrotating relative to each other, which is also an important function inthe operation of some integrated controlled volume inflation-deflationdevice designs that are discussed below with respect to FIG. 9. Thepreventing of rotation is also a convenience to the user, as any portionof the controlled volume inflation-deflation device may be grasped whileknob 130 is rotated in directions ROTS and the desired rotation of theknob 130 relative to the proximal housing 140 will be obtained. In otherembodiments, it is contemplated that the functions of retaining pins 160and 162 may be performed by a structure within cowling 180, such asbeing incorporated by an interference stop and/or slot mechanism betweencowling 180 and proximal housing 140. In other embodiments, it iscontemplated that the stop surfaces 163 and 165 engage the distalhousing 102 and the threads 166 and 167 engage the proximal housing 140.In other embodiments, it is contemplated that the threads 166 and 167 beomitted and replaced with stop surfaces similar to stop surfaces 163 and165 that engage a surface or structure of distal housing 120. In otherembodiments, the retaining pins may engage the cowling and the proximalhousing to provide similar functions, as previously described. In otherembodiments, the plunger assembly 110, 174 and syringe body 112 may bedesigned engage/interference with each other to provide some or all ofthe functions of the retaining pins and their associated structures.

Indexing locks 152 and 154 retained or removably locked proximallybeyond or behind proximal end 155 of cowling 180 may define a deflationlatched position (in conjunction with the function of retaining pins 160and 162). At this deflation latched position, a balloon may subjected toa minimal or low pressure by the increase of VOL 1 to VOL 2 and resultin the withdrawal of fluid from the catheter's balloon inflation lumenand balloon to deflate the balloon.

In some embodiments, cowling 180 extends over gap 189 when latch 150 isin position INFLAT and over indexing locks 152 and 154 when in positionDEFLAT. For example, cowling 180 may cover potential pinch points oropenings when inflation-deflation device 100 is transitioned betweendeflation latched position DEFLAT and inflation latched position INFLAT(e.g., such as pinch points or openings between the proximal end ofdistal housing 120 and the distal end of proximal housing 140). Oneembodiment of this is described below in reference to FIG. 4.

FIG. 4 is a schematic cross-sectional side view of a cowling and distalhousing of an inflation-deflation device according to one embodiment.FIG. 4 shows structure 400 having distal end 104, stop 490, and proximalend 106. Structure 400 includes cowling 480 attached to distal housing420 having longitudinal axis LAX. Distal housing 420 may be a distalhousing as described above with respect to housing 120. Cowling 480includes recess 482, such as a recess including recesses 182 and 184 asshown and described above with respect to FIG. 1A. In addition, cowling480 includes recess 486, such as a recess to provide the DEFLAT positionfunctionality described above with respect to proximal end 155 ofcowling 180 of FIG. 1. Other than recess 482 and recess 486, cowling 480may be similar to cowling 180 as described above with respect to FIGS.1A and 2.

It is contemplated that structure 400 may be used as part of aninflation-deflation device, such as in place of distal housing 120 andcowling 180 as shown in FIGS. 1-3. Thus, structure 400 (e.g., the innersurface of cowling 480, stop 490, and recesses 482 and 486 may form alatch with proximal housing 140, locks 152 and 154, and pins 160 and 162of FIGS. 1-3). For example, indexing locks 152 and 154 of proximalhousing 140 may engage recess 482 when the controlled volumeinflation-deflation device is in the inflation latched position and mayengage recess 486 when the controlled volume inflation-deflation deviceis in the deflation latched position. These inflation and deflationlatched positions may correspond to inflating or deflating a balloondescribed above with respect to recesses 182 and 184, and end 155 ofFIGS. 1A and 2.

In addition, when the inflation-deflation device is in the inflationlatched (first) position, a proximal end of distal housing 420 orportion of cowling 480 may be adjacent to, abutted against,superadjacent to, or pressed against a portion of proximal housing 140.For example, a distal end of proximal housing 140 may be abutted orpressed against stop 490 of cowling 480. Also, stop 490 may be adesigned stop adjacent to recess 482 to position indexing locks 152 and154 relative to recess 482 such that a sufficient force is generated tokeep proximal housing pressed against stop 490 during balloon inflationusing knob 130 or upon the transition from the DEFLAT position to theINFLAT position. Also, stop 490 may be a stop to prohibit plunger 110from moving to an undesired position along length L, such as a positionwhere the plunger 110 may engage the distal end of syringe body 112before the maximum number of incremental inflation volumes may besupplied by rotating knob 130. In other words, indexing locks 152 and154 will be prohibited from moving further distally because a distalsurface of proximal housing 140 will abut against stop 490 and prohibitproximal housing 140 from moving distally with respect to distal housing420.

Also, pins 160 and 162 may restrain structure 400 from being pulled awayfrom proximal portion 140 such that the locks do not move distal torecess 486, and do not slip out from under the inner surface of cowling480. Thus, pins 160 and 162 may have an appropriate length to prohibitlocks 152 and 154 from being exposed or slipping out proximally toproximal end 455 of structure 400. Alternatively, in some embodiments,retaining pins 160 and 162 may have a length selected to allow locks 152and 154 to extend proximally beyond proximal end 455, such as to definean additional releasably latched position for the inflation-deflationdevice.

As shown in FIG. 4, recess 482 and recess 486 may be grooves extendingradially around the inner surface of cowling 480, such as grooves havingbeveled sidewalls such as described for beveled sidewall BV1 of FIG. 1B.It is contemplated that recess 482 may be a groove having various othercross-sectional profiles sufficient to be engaged by indexing locks asdescribed herein. Thus, when indexing locks 152 and 154 engage recess482, the inflation-deflation device may be held or releasably latched inposition INFLAT and when the indexing locks engage recess 486, theinflation-deflation device may be held or releasably latched in (second)position DEFLAT, as described above with respect to FIGS. 1A and 2.

Thus, releasable latch 150 may be described as including cowling 180,recesses 182 and 184, inner surface ISUR, stop 190, indexing locks 152and 154, and retaining pins 160 and 162. As such, latch 150 may be movedbetween an inflation latched and deflation latched position so thatplunger 110 of inflation-deflation device 100 may be moved from aposition where controlled volume inflation-deflation device 100 inflatesan occlusion balloon sufficiently to occlude a blood vessel, to aposition where inflation-deflation device 100 retracts a volume of fluidfrom the occlusion balloon to allow blood to perfuse around theocclusion balloon and into the blood vessel. Since latch 150 can berepeatedly releasably locked or latched to the inflation latched anddeflation latched positions, it can be appreciated that the occlusionballoon can be repeatedly inflated to occlude the blood vessel anddeflated to perfuse fluid to the blood vessel. For example, latch 150can be used during treatment of a blood vessel without a substantialrisk of over-inflating the occluding balloon, because the same inflationor occlusion volume VOL 1 will be provided each time latch 150 is lockedin the inflation latched position INFLAT, and the same deflated orperfusing volume VOL 2 will be provided each time latch 150 is locked inthe deflation latched position DEFLAT.

When in position INFLAT, volumes of fluid may be pushed by plunger 110to inflate an occlusion balloon, such as incremental equal volumes asdescribed above, such as to push an inflation or occlusion volume into aballoon to occlude a blood vessel. For example, FIG. 3 is a schematicpartial see through side view of the inflation-deflation device of FIG.1A inflating a balloon to occlude a blood vessel at a region ofinterest. FIG. 3 shows inflation-deflation device 100 in inflationlatched position INFLAT, and having plunger holder 172 moved towardsdistal end 104 to push plunger 110 to location L3 along length L. Asnoted above, plunger holder 172 has threads corresponding to those ofscrew mechanism 170 and thus may be moved towards distal end 104 byrotating knob 130 in one direction of rotational directions ROTS.Similarly, it can be appreciated that by rotating knob 130 in theopposite direction of that used to move plunger holder 172 towardsdistal end 104 may be used to move plunger holder 172 towards proximalend 106, such as to retract plunger 110 towards proximal end 106.Moreover, as described above, knob 130 may be rotated so thatincremental equal volumes of fluid are pushed out or withdrawn from tip113. For instance, recesses similar to recesses 142 and 144 may bespaced along the surface of proximal housing 140 to be engaged byindexing locks 132 and 134 so that when knob 130 is rotated, therecesses are engaged by the indexing locks when plunger 110 is moved toa location along length L to push or retract equal volumes of fluid fromtip 113. During rotation, window 141 may display indicia as describedabove. In addition, window 141 may display indicia, such as a number orsymbol, indicating an increment count, expelled incremental volume or avolume within syringe tube 112 in front of plunger 110 associated withthe current rotational position of knob 130 and/or plunger holder 172with respect to proximal housing 140. For example, in FIG. 3, thenumeral “10” is displayed in window 141 and may indicate that ten (10)incremental volumes of fluid have been expelled to inflate balloon 348.

It can be appreciated that knob 130 may be rotated to positions at whichindexing locks in knob 130 (e.g., locks similar to locks 132 and 134)engage recesses of proximal housing 140 (e.g., recesses such as recesses142 and 144) to communicate (e.g., by pushing out or retracting intosyringe tube 112) incremental volumes of fluid through tip 113.Specifically, when rotating knob 130, one or more indexing locks of knob130 may engage one or more recesses of proximal housing 140 to moveplunger 110 to locations or positions along length L that are equallyspaced, such as to change volume VOL3 in syringe tube 112 by incrementalequal volumes of fluid. Moreover, it is contemplated that knob 130 maybe rotated to move plunger 110 along length L, as described above, wheninflation-deflation device 100 is in position INFLAT, position DEFLAT,or a mid-latched position as described below.

In addition, FIG. 3 shows inflation-deflation device 100 attached tocannula 312, such as a catheter, stopcock, or extension tube that may inturn be attached to cannula 392 having balloon 348 attached at oradjacent a distal end thereof. Balloon 348 is shown occluding bloodvessel 390 near region of interest 396. Specifically, balloon 348 isinflated with a sufficient volume or pressure of fluid to prohibit bloodfrom flowing in directions DIRS, such as to prohibit blood from flowingby balloon 348. Moreover, cannula 392 is shown with infusion opening394, such as an opening or lumen through which a treatment agent may beinfused into blood vessel 390. Cannula 392 may be an infusion catheterfor infusing a treatment agent into blood vessel 390 and/or inflatingballoon 348, such as to occlude blood vessel 390 or for other purposes,such as introducing an imaging agent or a flush for enhancing the energytransfer of a photodynamic therapy light and the like into the vessel.In some embodiments, opening 394 may be positioned proximal of theballoon. In some embodiments, cannula 392 may contain multiple infusionlumens and multiple openings 394. In some embodiments, cannula 392 maycontain other elements such as imaging devices, sensors, fiber opticcables and the like.

In some embodiments, after balloon 348 and cannula 392 are advanced toregion of interest 396 of blood vessel 390 with inflation-deflationdevice 100 locked into inflation latched position INFLAT, knob 130 isrotated to advance plunger 110 towards distal end 104 until a sufficientvolume of fluid inflates balloon 348 to occlude blood vessel 390. Afterblood vessel 390 is occluded, a treatment or other agent may be infusedvia infusion opening 394 to region of interest 396. Alternatively, itshould be appreciated that the treatment or other agent may be infusedproximal to balloon 348.

Next, according to embodiments, before or after infusing a treatment orother agent, inflation-deflation device 100 may be transitioned todeflation latched position DEFLAT to withdraw a sufficient volume offluid from balloon 348 to allow perfusion of blood vessel 390. Forexample, when inflation-deflation device 100 is transitioned positionDEFLAT (as shown in FIG. 2) causing balloon 348 to deflate such thatblood in blood vessel 390 may perfuse in directions DIRS to go by orpast balloon 348. Note that the difference between volume VOL2 and VOL3may be selected by selecting the appropriate lengths of cowling 180and/or retaining pins 160 and 162 in directions DIR and/or selecting alocation of recesses 182 and 184 and stop 190 along the inner surface ofcowling 180. For instance, recesses 182 and 184 and the position of stop190 and the length of cowling 180 and/or retaining pins 160 and 162 maybe chosen to space proximal end 155 a distance away from recesses 182and 184 and stop 190 to move plunger 110 a desired distance along lengthL to create the difference in volumes between volumes VOL3 and VOL2 asselected.

Thus, latch 150 and structures thereof may lock latch 150 at positionINFLAT and position DEFLAT (and mid-latched positions as describedfurther below for FIGS. 5,6 and 10) with sufficient force that latch 150stays locked or latched in those positions until distal housing 120 andproximal housing 140 are physically forced or pushed closer together orpulled farther apart, such as by human hands to transition the device100 from one position to another position. Specifically, similarly tothe description above with respect to FIG. 1B, indexing locks 152 and154 may engage recesses 182 and 184, and may engage proximal end 155,with sufficient force to hold latch 150 in position when plunger 110 isholding a pressure or volume of fluid in balloon 348 sufficient toocclude or perfuse blood vessel 390. In addition, as described abovewith respect to manipulating knob 130 with a hand, distal housing 120and proximal housing 140 may be pushed together or pulled apart by humanhands to transition latch 150 between position INFLAT, position DEFLAT,and mid-latched positions as described below.

Although specific structures are described above with respect to FIGS.1A-C, 2, and 3, variations are contemplated. For example, where dualstructures are described, such as indexing locks, recesses, andretaining pins, a single device or set of devices may be used whensufficient. In addition, more than two devices may be used. Also,although indexing locks 132 and 134 are described on knob 130 andrecesses 142 and 144 are described on proximal housing 140, the positionof those structures may be reversed. For example, indexing locks 132 and134 may be located on or in proximal housing 140 while recesses 142 and144 are located in knob 130. Similar feature position reversals arecontemplation for indexing locks 152 and 154 and recesses 182 and 184.Similarly, it is considered that cowling 180 may be attached to proximalhousing 140 and indexing locks 152 and 153 may be part of distal housing120. Moreover, retaining pins 160 and 162 may be attached to proximalhousing 140 and have stop surfaces for engaging a surface of distalhousing 120.

Also, it is considered that components or structures ofinflation-deflation device 100 may be formed of various materials, suchas metal, plastic, polymer, glass, paper, and the like. Likewise, thematerials may be formed by various processes including machining,molding, injection molding, casting, forging, extruding, co-extruding,and the like.

According to some embodiments, the described controlled volumeinflation-deflation device 100 and 200 may be used as part of aninflation system to inflate an occlusion balloon to an initial OD withanother device, then use the controlled volume inflation-deflationdevice to increment the balloon OD to obtain the initial occlusion, aswell as to inflate and deflate an occlusion balloon. Such an inflationsystem may be desirable, as the amount of fluid required to initiallyinflate a balloon to its nominal or beginning OD may require aninconveniently large number of volume increments (counter increments oramount of knob turning), especially of volume increments small enough toincrement the balloon OD in small enough increments to avoidover-expanding the vessel to obtain an occlusion. Controlled volumeinflation-deflation devices that do not provide for the convenientinitial inflation of a balloon to its nominal of beginning OD arereferred to as non-integrated controlled volume inflation-deflationdevices. For example, FIG. 14 is a schematic side view of one embodimentof an inflation system including a partial see through side view of acontrolled volume inflation-deflation device attached to a to a stopcockthat is attached to a catheter having a balloon at its distal end andattached to a conventional low pressure inflation-deflation device thatperforms the initial inflation of a balloon using a pre-determinedinflation pressure. FIG. 14 shows system 1400 to inflate an occlusionballoon to an initial OD using a conventional low pressureinflation-deflation device or syringe 1420, then use the controlledvolume inflation-deflation device 1410 to increment the balloon OD toobtain the initial occlusion, as well as to inflate and deflate anocclusion balloon. FIG. 14 shows non-integrated controlled volumeinflation-deflation device 1410, similar to controlled volumeinflation-deflation devices 100 and 200, attached to 2-WAY stopcock 1030that is attached to occlusion infusion catheter 1040 having an occlusionballoon at its distal end, and attached to a conventional low pressureinflation-deflation device 1420 or low volume syringe device 1420. Aconventional low pressure inflation-deflation device 1420 may be used toinject fluid at a sufficient pressure into the catheter and balloon(e.g., a low pressure between 1 and 0.5 ATM) to obtain the initialinflation the balloon to its formed, beginning or initial OD (preferablyan OD that is at or below the balloon OD required to occlude thevessel). The formed OD of a balloon is often referred to as the nominalOD of the balloon. A conventional low pressure inflation-deflationdevice 1420 may be used for the initial inflation of non-compliant,compliant and elastic balloons that have a formed ID that is larger thatthe OD of the catheter shaft that the balloon is mounted on. Usuallysuch a balloon is folded onto the catheter shaft in the deflatedcondition when removed from its packaging. Inflating to a low pressureassures that the balloon will not over-expand the vessel, if the formedOD of the balloon appreciably exceeds the ID of the vessel.Alternatively, a low volume syringe device 1420 may be used to initiallyinject a pre-determined volume of fluid into the balloon to inflate itto its formed or beginning OD. If the balloon is an elastic balloon witha formed ID very close to the OD of the catheter shaft that it ismounted on and the desired beginning OD of the elastic balloon issignificantly larger than its formed OD, then it is preferred that theballoon be initially inflated with a pre-determined volume of fluidusing a low volume syringe device 1420. This is because OD's of elasticballoons above their formed OD are very difficult to control bycontrolling the pressure of the fluid injected into the balloon.

Device 1410 in FIG. 14 may be described as a non-integratedinflation-deflation device, since device 1410 requires assistance fromanother inflation device (e.g., device 1420) to conveniently initiallyinflate an occlusion balloon to a nominal or beginning OD from a minimalOD (the initial balloon inflation function is not integrated into thecontrolled volume inflation-deflation device). However, once the balloonis inflated to the nominal or beginning OD, device 1410 is able toinflate the balloon to an OD sufficient to occlude a blood vessel, andto deflate the balloon to a sufficient OD to allow the balloon to beadvanced or withdrawn within a blood vessel, or to allow perfusion of ablood vessel. Also, according to some embodiments, inflation-deflationdevice 1410 may be a controlled volume inflation-deflation device suchas inflation-deflation device 100, 200 or an inflation-deflation devicehaving structure 400 as described herein.

Device 1420 may be a conventional low pressure inflation-deflationdevice, preferably including a pressure gauge capable of readingpressures of 1 ATM or less to facilitate an initial occlusion ballooninflation to a low pressure. Alternately, device 1420 may be a lowvolume syringe, preferably 1 cc or less with sufficient graduation marksto facilitate an initial occlusion balloon inflation with a controlledvolume of fluid.

According to some embodiments, device 1410, stopcock 1030, and/or device1420 are attached to catheter 1040 after the catheter is aspirated andin position in the vessel and is used to initially inflate the balloonto a pre-determined low pressure or pre-determined volume (using device1420) and then adjust the balloon OD in increments until occlusion usingthe knob of device 1410 and then deflating the balloon by moving thelatch of device 1410 to its (most proximal) deflation position and theninflating/deflating the balloon to control the occlusion at will. Oncethe initial inflation is accomplished, the stopcock may be turned anddevice 1420 disconnected. The aspiration of the balloon may be performedwith catheter 1040 in the vessel or outside the body, and is preferredto be performed prior to attaching device 1410, stopcock 1030, and/ordevice 1420 to catheter 1040, such as using a syringe.

Furthermore, an example process for using system 1400, or a like system,is described by the following operations:

-   1. Aspirate air from the occlusion balloon and balloon inflation    lumen of catheter 1040 using an aspiration syringe (e.g., a 20 cc    syringe). Aspiration is a process by which air is removed from the    occlusion balloon and balloon inflation lumen and replaced by a    fluid. The compressibility of air interferes with the control of the    balloon OD.-   2. Assemble and de-bubble stopcock 1030, device 1420, and device    1410 (in the first latched or inflation latched position) using a    wet connection process. A wet connection process is when the fluid    connectors of devices are wetted/filled with fluid prior to being    mated. This helps the mated connection to be air and fluid tight and    avoids introducing air into the connection during mating.-   3. Position the occlusion balloon at the desired occlusion position    in the vessel.-   4. Attach that inflation assembly from operation 2 to the balloon    inflation lumen of catheter 1040 using a wet connection. At this    point, the wet connection may force some fluid into the catheter    1040, causing the balloon to partially inflate. If the balloon must    be re-positioned or the user will not immediately perform operation    5, then the syringe of device 1420 may be retracted slightly to    ensure the complete deflation of the balloon.-   5. Using device 1420, inflate the balloon to its initial inflation    pressure (e.g., to an initial or formed OD, such as by inflating    with a pressure of 0.5 ATM) or to its initial inflation volume, then    remove device 1420 from the balloon inflation fluid path by turning    stopcock 1030 and disconnect and remove device 1420 from stopcock    1030.-   6. Determine if blood vessel that balloon is in is occluded as    desired.-   7. If vessel is not occluded at the initial balloon OD, turn knob of    device 1410 to largest safe OD, as indicated by a previous    fluoroscopic or other image of the vessel and a chart of the    expected balloon OD to knob increment count.-   8. Determine if blood vessel that balloon is in is occluded as    desired. The occlusion may be tested, such as by contrast injections    (e.g., via a guide catheter) or pressure readings (e.g., via a    catheter 1040 lumen, a catheter 1040 infusion lumen).-   9. If vessel is not occluded, increment balloon OD by turning knob    of device 1410 another increment.-   10. Repeat steps 8-9 as necessary to provide the initial occlusion.-   11. Transition the controlled volume inflation-deflation device 1410    to the deflation (second) latched position to deflate the balloon    and allow blood flow in the vessel.-   12. Perform the medical treatment or procedure, occluding the vessel    by transitioning the controlled volume inflation-deflation device    1410 to the inflation (first) latched position and removing the    occlusion by transitioning controlled volume inflation-deflation    device 1410 to the deflation (second) latched position as required.-   13. When the medical treatment or procedure is complete, ensure the    controlled volume inflation-deflation device 1410 is in the    deflation (second) latched position (balloon deflated), remove the    controlled volume inflation-deflation device 1410 from the catheter,    and then remove the catheter 1040 from the vessel.

It is contemplated that operations in addition to those above may beperformed when using system 1400 or a like system. Also, in some cases,fewer than all of the operations above may be performed when usingsystem 1400 or a like system. Likewise, in some cases, the order of someof the operations above may be switched around when using system 1400 ora like system. Moreover, according to some embodiments, the operationsabove may include those described with respect to the processes of FIG.11.

To create an integrated controlled volume inflation-deflation devicethat conveniently performs an initial inflation of the balloon with apredetermined volume of fluid, the design of controlled volumeinflation-deflation device 100 may be modified. Referring back to FIGS.1A and 2, latch 150 may define at least one mid-latch position(s)between inflation latched and deflation latched positions. For instance,according to some embodiments, indexing locks 152 and 154 may engagevarious other recesses along the inner surface ISUR of cowling 180 todefine another latched position, and/or various mid-latched positionsbetween the inflation latched and deflation latched positions, such aswill be described further below.

FIG. 5 is a schematic cross-sectional side view of a cowling and distalhousing of an integrated controlled volume inflation-deflation deviceaccording to an embodiment. FIG. 5 shows structure 500 having cowling580 attached to distal housing 520 having longitudinal axis LAX. Cowling580 includes recess 582, 588, and 586. Distal housing 520 may be adistal housing as described above with respect to housing 420. Recess582 may be a recess as described above with respect to recess 482.Similarly, recess 586 may be a recess as described above with respect torecess 486. Moreover, other than recess 588, cowling 580 may be acowling as described above with respect to cowling 480. Also, FIG. 5shows cowling 580 including recess 588, such as a mid-recess ormid-beveled groove extending along the inner surface of cowling 588radially between recess 582 and recess 586.

Similar to the description above with respect to structure 400 of FIG.4, structure 500 may be used as part of an integrated controlled volumeinflation-deflation device, such as to replace distal housing 120 andcowling 180 as shown in FIGS. 1A, 2 and 3 to form an integratedcontrolled volume inflation-deflation device. Specifically, a latch maybe formed including recesses 582, 588, and 586 being engaged by locks152 and 154 to be held or releasably latched. More particularly, FIG. 5shows structure 500 including proximal end 555 which may functionsimilarly to proximal end 455 as described above with respect to FIG. 4,and stop 590 which may function similarly to stop 190 of FIG. 1A and/orstop 490 of FIG. 4. Thus, when recess 588 is engaged by indexing locks152 and 153, latch 150 or the inflation-deflation device may define amid-latched position to removably position plunger 110 at a positionbetween location L1 and location L2. Locks 152 and 154 engaging recess586 may correspond to the balloon deflation position DEFLAT as describedabove with respect to end 155 of FIG. 2. Likewise, locks 152 and 154engaging recess 582 may correspond to balloon inflation position INFLATas described above with respect to recesses 182 and 184 of FIG. 1A.However, if the integrated controlled volume inflation-deflation deviceis attached to the balloon inflation lumen while in the mid-position(locks 152 and 154 engage recess 588) and then the latch mechanism ismoved to the INFLAT position, the plunger 110 will be moved apredetermined distance inside syringe tube 112 to force a pre-determinedvolume of fluid into the balloon to initially inflate the balloon to apre-determined OD.

For example, FIG. 6 is a schematic partial see through side view of anintegrated controlled volume inflation-deflation device having a latchin a mid-latched position. FIG. 6 shows inflation-deflation device 600having structure 500 (FIG. 5) where recess 588 is engaged with indexinglocks 152 and 154. Thus, FIG. 6 includes gap 689 between distal housing520 and proximal housing 140 or stop 190 where gap 689 is shorter inlength than gap 189 of FIG. 2. Correspondingly, plunger 110 is atlocation L4 along length L within syringe tube 112. Thus, syringe tube112 may hold volume VOL4 of fluid which is greater than volume VOL1, butless than volume VOL2 (e.g., location L4 is proximal to location L1 asshown in FIG. 1A).

For example, mid-latched position MID as shown in FIG. 6 may be used toremovably lock latch 650 in a mid-latched position after the syringetube 110 has been filled with contrast or other fluid and de-bubbled,creating a filled VOL 4. Transitioning the latch 650 to the INFLATposition will inflate balloon 648, attached at or adjacent to a distalend of cannula 692 which is coupled to tube 612 attached to tip 113 ofcontrolled volume inflation-deflation device 600, with a pre-determinedvolume of fluid, such as after balloon 648 and cannula 692 are aspiratedand percutaneously advanced through a blood vessel to a region ofinterest. A pre-determined volume may be a volume of fluid to inflate aballoon with a sufficient amount of contrast or other fluid so that theballoon may be inflated to its nominal or desired beginning OD. Forexample, the injection of a pre-determined volume may be sufficient toinflate a balloon to a nominal OD or initial OD within a blood vesselthat may or may not be an OD sufficient to occlude the blood vessel.Note that an initial inflation, volume, pressure, OD, and the like mayrefer to the first intentional inflation of the balloon using aninflation device such as a syringe or inflation-deflation device, forthe current use or procedure, or for the current region of interest. Adeflation pressure or volume may be defined as a pressure or volume offluid at which the pressure of the fluid on the walls of the balloon andsubsequently in the catheter or conduit through which the fluid iscommunicated with the balloon is at a lower pressure than the blood inthe vessel and sufficiently low to cause flow out of the balloon. Forexample, a deflation pressure or volume may be sufficient to deflate aballoon to a minimal OD sufficiently rapidly to allow the balloon to beconveniently advanced or withdrawn within a blood vessel, or to allowperfusion of a blood vessel when desired. In some cases, a deflationpressure or volume may represent the pressure or volume of an aspirationfluid or liquid, such as fluid or liquid used to fill an inflationsystem, an inflation-deflation device and/or catheter to be free of airor gas to minimize “bubbles” in the liquid or fluid in communicationwith the occlusion balloon. Such a fluid or liquid may be a contrastsolution. A device or system that has had its air removed and replacedwith a fluid is said to have been aspirated. Also, the deflationpressure or volume may define a single or different pressures or volumesfor any single balloon. Those pressures or volumes may also define arange of pressures and volumes for a single balloon. Moreover, they maydefine a single, different, and/or a range of pressure and volumes forvarious balloons having different sizes, shapes, materials, andthicknesses.

Furthermore, as shown in FIG. 6, it is considered that retaining pins660 and 662 may have an appropriate length to prohibit indexing locks152 and 154 from moving further towards proximal end 106 than recess586. Thus, in one embodiment, indexing locks 152 and 154 do not moveproximally beyond proximal end 555 of cowling 580 and are not exposed(e.g., indexing locks are kept along the inner surface of cowling 580).Alternatively, in some embodiments, retaining pins 660 and 662 may havea length to allow indexing locks 152 and 154 to extend proximally beyondproximal end 555, such as to define a releasably latched position oflatch 650, where locks 152 and 154 are locked at proximal end 555, suchas the description above with respect to those locks and proximal end155 of FIG. 2. In such a situation recess 586 may define anothermid-latch position that may be used for the initial inflation of adifferent balloon, a balloon with a larger formed volume, or the sameballoon to a larger initial OD. In some embodiments, multiple mid-latchpositions may be provided.

FIG. 8 is a schematic cross-sectional side view of a retaining pin of acontrolled volume inflation-deflation device having a recess engaged byan index lock of the proximal housing of the controlled volumeinflation-deflation device. FIG. 8 shows structure 800 includingretaining pin 860 attached to distal housing 820 by threads 868.Retaining pin 860 also has stopping surface 863 within space 847 ofproximal housing 840. Proximal housing 840 includes housing stop surface842. Thus, when distal housing 820 and proximal housing 840 are movedaway from each other, stop surface 863 may engage, abut against, or stopat housing stop surface 842 to prohibit proximal housing 840 fromextending a selected distance away from distal housing 820. In addition,FIG. 8 shows pin 860 having pin recesses 862, 864, and 866 along thelength of the pin. Recesses 862, 864, and 866 may be beveled grooves,holes or other recesses or structures to hold a releasably latchindexing lock as described above with respect to recess 142 and FIG. 1B.For instance, recesses 862, 864, and 866 may each be a radial groove ata location along a length of the retaining pin to engage an indexinglock. Proximal housing 840 is shown with indexing lock 852 releasablylatched or locked to pin recess 866.

It is contemplated that structure 800 may be used as part of acontrolled volume inflation-deflation device, such as in place of pins160 and 162 and the releasable latches of FIGS. 1A, 2-6 (e.g., structure800, without groove 864, may obviate the need for locks 152 and 154, andrecesses 182 and 184 of FIGS. 1A, 2 and 3, and recesses of structure 400of FIG. 4 and, with groove 864, the recesses of structure 500 of FIGS. 5and 6). Thus, structure 800 (e.g., lock 852 engaging recesses 862, 864,and 866) provide the functionality of releasable latch 150 and acorresponding releasable latch of including structure 400 and 500 ofFIGS. 4-6 to releasably lock an inflation-deflation device in aninflation latched position (e.g., position INFLAT of FIGS. 1A and 3),deflation latched position (e.g., position DEFLAT of FIG. 2), and/ormid-latched position(s) (e.g., position MID of FIG. 6). For example,indexing lock 852 of proximal housing 840 may engage recess 862 when thecontrolled volume inflation-deflation device is in the inflation latchedposition, may engage recess 864 when the device is in a mid-latchposition, and may engage recess 866 when the device is in the deflationlatched position to move plunger 110 along length L similarly to thefunction of those positions as described above for FIGS. 5 and 6.

Indexing lock 852 may engage recesses 862, 864, and 866 similarly to thedescription above with respect to indexing lock 152 engaging recesses582, 588, and 586 as shown and described with respect to FIGS. 5 and 6,to define an inflation latched, a mid-latched, and a deflation latchedpositions, such as positions that may correspond to inflating a balloonwith a pre-determined inflation volume as described above with respectto those recesses. Thus, similarly to the description above with respectto using recesses 182 and 184, or other recesses of FIGS. 4-6 to beengaged by indexing locks 152 and 154, pin recesses 862, 864, and 866may provide releasable latch 850.

Also, pin 860 may be a pin as described above with respect to pin 160,and surface 863 may be a surface as described above with respect tosurface 163, such as to restrain or restrict movement of the proximaland distal housing sections when the controlled volumeinflation-deflation device is in the deflation latched position to stopindexing locks at recesses, distal to a proximal end of a cowling, orproximal to a proximal end of a cowling. Thus, in some cases, retainingpins 160 and 162 may be pin 860 of FIG. 8 without pin recesses 862, 864,and 866 along the length of the pin.

In addition, it is also contemplated that structures like housing stopsurface 842 and retaining pin stop surface 863 may be used to attach apin like pin 860 to a distal housing or to prevent a pin like pin 860from disengaging from a distal housing. Also, it is contemplated thatpin recesses 862, 864, and 866 may be engaged by an indexed lock ofeither the distal or proximal housing in either of the configurationsdescribed above (e.g., regardless of whether threads 868 are attached toa distal or proximal housing).

FIG. 9 is a schematic cross-sectional see-through side view of a cowlingand distal housing of an integrated controlled volumeinflation-deflation device that conveniently inflates balloons to aninitial OD using pre-determined inflation volumes and having arotational index and recesses along a longitudinal length of the innersurface of the cowling and corresponding to indexing positions of therotational index. One way that housing and cowling of structure 900 ofFIG. 9 is different from those of structure 400 of FIG. 4 is that instructure 900 they are separated into two separate components, while instructure 400 they can be a single component. FIG. 9 shows structure 900having distal housing 920 rotationally coupled to cowling 980 byrotational indexing device 956. Indexing device 956 may include thedistal portion of cowling 980 with recesses and indexing lock 958 toengage those recesses. Cowling 980 includes recesses 987, 988, 989, 982,992, 994, 996, 998, and 986. Distal housing 920 has longitudinal axisLAX and includes indexing lock 958. Other than indexing lock 958 and theseparation of the cowling 980 from the distal housing 920, distalhousing 920 may be similar to distal housing 520. Recesses 982 and 986may be similar to recesses 582 and 586. Also, lock 958 may be a ballnose spring plunger or other structure such as those described abovewith respect to indexing lock 132 and FIG. 1B. Likewise, recesses 987,988, 989, 992, 994, 996, and 998 may be beveled grooves, holes or otherrecesses or structures to hold a releasably latch indexing lock asdescribed above with respect to recess 142 and FIG. 1B. Recesses 987,988 and 989 may further be deeper parts of a radial groove around theinside circumference of the distal end of cowling 980, such thatindexing lock 958 retains cowling 980 on the proximal end of distalhousing 920. Alternatively or in addition, other mechanical structuresmay be provided to retain the longitudinal relative position of thedistal housing 920 to the cowling 980, while allowing them to rotaterelative to each other.

Rotational indexing device 956 may include indexing lock 958 to hold orreleasably lock in rotational positions with respect to axis LAX byengaging recess 987, 988, or 989 to index rotation of cowling 980 withrespect to distal housing 920 at positions defined or selected by thelocation of recess 987, 988, and 989. Specifically, cowling 980 may berotated with respect to distal housing 920 in directions IR aroundlongitudinal axis LAX to engage recess 987, 988, or 989 with lock 958.Moreover, recesses 992, 994, and 996 may correspond to the rotationalpositions defined by the location of recesses 987, 988, and 989, whererecesses 982, 984, and 996 are spaced along length ML between recesses982 and 986.

In some embodiments the indexing lock is a ball nose spring plunger, around nose spring plunger, a radial spring, or an o-ring (e.g., see FIG.1E). Also, the cowling recess may be a hole in the cowling, a blind holein the inner surface of the cowling, such holes with beveled and/orstraight sidewalls, or a beveled and/or straight sided groove extendingradially around the inner surface of the cowling with respect to alongitudinal axis of the proximal housing. In some cases, a cowlingrecesses (e.g., recess 992, 994, 996, and/or 998) may be square, acounterbored blind hole, or a drilled through hole with or withoutbeveled sides. For instance, a round or circular hole may be usedbecause a square recess may be quite a bit more difficult to fabricatethan the circular recess (e.g., than just a drilled hole). It can beappreciated that such recesses may be designed with any number of sidesto engage the index lock(s) in a desired manner. As mentioned above, inany instance described herein of an indexing lock and recess, thestructure or location of the indexing lock and recess may be reversed,where possible.

Similar to the description above with respect to structure 400 of FIG.4, structure 900 may be used as part of a controlled volumeinflation-deflation device, such as by replacing distal housing 120 andcowling 180 as shown in FIGS. 1A, 2 and 3. Thus, structure 900,including device 956; recesses 982, 992, 994, 996, 998, and 986; locks152 and 154; and pins 160 and 162 may form a latch to select between aninflation latched position, a deflation latched position, and variousmid-latched positions, if applicable, as described above with respect toFIGS. 1A, 2-6 and 8. Specifically, when lock 958 engages recess 987,988, or 989, lock 152 may engage the corresponding one of recess 992,994, and 996 along length ML to locate plunger 110 at a location alonglength L when structure 900 is incorporated as part of a controlledvolume inflation-deflation device, such as to lock in a mid-latchedposition. Hence, in an integrated controlled volume inflation-deflationdevice, structure 900 may provide a functionality similar to structure500 in its ability to provide various predetermined volumes of fluid tovarious occlusion balloons, such as after the balloons are aspirated andadvanced to a region of interest of a blood vessel. For example, byrotating cowling 980 in directions IR, lock 958 may lock to recesses987, 988, or 989 to removably lock rotational indexing device 956 atrotational positions to locate plunger 110 between location L1 and L2 asdescribed above with respective FIGS. 1A and 2, when lock 152 engagesrecesses 992, 994, or 996 to latch the inflation-deflation device atvarious mid-latched positions. Likewise, lock 152 engaging one ofrecesses 992, 994, and 996 and then transitioning the latch to theinflation latched position (lock 152 engaging recess 982) may correspondto inflating a balloon with a pre-determined inflation volume asdescribed above with respect recess 588 of FIG. 5. Recall that theproximal housing 140 may not rotate relative to the distal housing 920due to retaining pins 160 and 162, thus the paths of indexing locks 152and 154 may only encounter one pair of recesses like recesses 992, 994,or 996 and their corresponding mates. Also, locks 152 engaging recesses982 may correspond to the inflation latched position as described abovewith respect to recesses 582 of FIG. 5.

It can be appreciated that recesses similar to 992, 994, and 996 mayexist for engagement of locks other than lock 152. Specifically, FIG. 9shows recess 998, such as a recess corresponding to recess 992 but foran indexing lock other than lock 152. Thus, while lock 152 is engagingrecess 992, another lock, such as lock 154, may engage recess 998, andwhen lock 152 engages recess 994, the corresponding lock may engage arecess at a position along length ML similar to that of recess 994, andwhen lock 152 engages recess 996, a corresponding lock may engage arecess along length ML at a position similar to that of recess 996. Itis also contemplated that structure 900 may include a stop similar tostop 490 as described above with respect to FIG. 4 and a proximal endsimilar to proximal end 455 as described above with respect to FIG. 4.

Furthermore, distal housing 920 may include index locks in addition tolock 958, and cowling 980 may include indexing recesses in addition torecesses 987, 988, and 989. Similarly, cowling 980 may include recessesfor additional indexing positions and may include additionalcorresponding recesses or locks at various positions along length MLsimilarly to the description of various mid-latch positions above withrespect to structure 500. As such, when incorporated in a controlledvolume inflation-deflation device, structure 900 may be used to providepre-determined volumes of fluid to various volumes, sizes, and designsof occlusion balloons after the balloons are aspirated and advancedthrough a blood vessel and positioned at a region of interest.

In other embodiments, cowling 980 and distal housing 920 may containfeatures that indicate the particular mid-latch position that thecurrent rotational orientation of the cowling 980 relative to distalhousing 920 corresponds to in a manner that allows the user to adjustthe rotationally orientation to the mid-latch position that correspondsto the initial inflation volume or OD of the balloon in use. Forinstance, a pointing mark can be printed on the OD of cowling 980 thatpoints toward a series of symbols or marks on the OD of distal housing920. Those symbols or marks would indicate the appropriate balloon orthe currently set initial inflation volume. In other embodiments, areleasably latched rotational orientation of the cowling 980 relative todistal housing 920 may not contain a mid-latched position. It ispreferred that an integrated controlled volume inflation-deflationdevice of this type be packaged such that no mid-latched position isselected. Thus, the operator is required to adjust the rotationalorientation of the cowling 980 relative to distal housing 920 to selectthe appropriate mid-latched position for the balloon in use or initialballoon OD desired. Otherwise, the operator will find a mid-latchedposition ready for use that may not be appropriate or safe for theballoon in use and the operator will not be reminded to adjust therotational orientation of the cowling 980 relative to distal housing 920to select the appropriate mid-latched position by being unable to find amid-latched position.

Also, according to some embodiments, for any of the inflation-deflationdevices described above with respect to FIGS. 1-9, the relationshipsand/or concepts described with respect to the cowling and the proximaland distal housings may be reversed. Specifically, the cowling may beattached to the proximal housing and have indexing/recess relationshipswith the distal housing (e.g., all references above to the proximal anddistal housings are exchanged).

Furthermore, prior to occluding a blood vessel with a balloon orinflating an occlusion balloon, it is desired to aspirate air or gasfrom within the catheter or balloon and replace it with fluid or liquidto provide better control and predictability of the inflation or outerdiameter of the balloon during inflation. This is because air or gascompresses much more than fluid or liquid when under pressure. Suchaspiration or air evacuation may be performed at low pressure, such aspressure below atmospheric pressure (e.g., below one (1) atmospheres(ATM), or approaching zero (0) pounds/square inch (PSI)). For example,FIG. 10 is a schematic side view of one embodiment of an inflationsystem including a partial see through view of an integrated controlledvolume inflation-deflation device that performs the initial inflation ofa balloon using a pre-determined inflation volume attached to anextension tube attached to a stopcock that is attached to a catheterhaving a balloon at its distal end and attached to an aspiration syringefor aspirating the balloon and catheter. FIG. 10 shows system 1000having aspiration syringe 1020 attached to detachable connector 1024 oftwo-way stopcock 1030, which is attached to catheter 1040 having balloon1048 attached at or near distal end 1046. System 1000 also includesintegrated controlled volume inflation-deflation device 1010 having tip1016 of syringe tube 1012 attached to connector 1054 of extension tube1050. Integrated controlled volume inflation-deflation device 1010 maybe a device similar to inflation-deflation device 600 described herein.Also, connector 1056 of extension tube 1050 is attached to connector1034 of stopcock 1030. Thus, extension tube 1050 may be attached andsealed (e.g., such as to form a fluid and air tight seal) to integratedcontrolled volume inflation-deflation device 1010 and stopcock 1030.Similarly, input adapter 1042 at proximal end 1044 of catheter 1040 maybe attached and sealed to distal connection 1026 of stopcock 1030. Theextension tube 1050 reduces the disturbance of the proximal end of thecatheter 1044 that may be introduced during the manipulation/use of theintegrated controlled volume inflation-deflation device 1010 and helpsprevent such things as catheter 1040 shaft kinking and undesiredcatheter 1040 position changes. In FIG. 10, the extension tube 1050 isshown connected to the system between the stopcock 1030 and thecontrolled volume inflation-deflation device 1010. In other embodiments,the extension tube 1050 may be connected between the stopcock 1030 andthe catheter 1040 (device 1010 connected to the stopcock 1030) oranother extension tube 1050 may be added to the system between thestopcock 1030 and the catheter 1040. In some cases, this extension tube1050 location(s) provides needed clearance between the stopcock 1030 andthe proximal end 1044 of the catheter. In some catheter 1040 designs,the proximal end 1044 of the catheter 1040 can be a very crowded placewith many adjacent connections that may require a more easy access thanis provided if the stopcock 1030 is connected to catheter proximal end1044 and must be manipulated there.

Controlled volume inflation-deflation device 1010 may be described as an“integrated” controlled inflation-deflation device because it is able toinitially inflate an occlusion balloon to a nominal or desired OD from aminimal OD, to inflate the balloon to an occlusion OD sufficient toocclude a blood vessel, to deflate the balloon to a sufficient OD toallow the balloon to be advanced or withdrawn within a blood vessel orto allow perfusion of the blood vessel, and then to re-inflate theballoon to the occlusion OD and deflate the balloon at will. Anintegrated controlled volume inflation-deflation device may be able toinitially inflate an occlusion balloon to a nominal or desired OD from aminimal OD without assistance from another inflation-deflation device,such as by “integrating” that ability with the controlled volumeinflation-deflation device's ability to inflate and deflate the balloonto occlude and perfuse the blood vessel. Moreover, an integratedcontrolled volume inflation-deflation device may be designed toinitially inflate an occlusion balloon to a nominal or desired OD from aminimal OD using a pre-determined inflation pressure or a pre-determinedvolume of fluid. The type of integrated controlled volumeinflation-deflation device that initially inflates the balloon to apre-determined pressure will be discussed later in reference to FIGS. 7,12 and 13. Note that the type of initial inflation of a balloon candepend on the design/material of the balloon. Some balloons are bestinitially inflated to a predetermined pressure and some balloons arebest initially inflated to a predetermined volume (e.g., to obtainnominal OD). A compliant balloon is a balloon that has an adjustable ODbeyond its formed OD, but will not return to its formed OD after havingbeen adjusted to its maximum OD. An elastic balloon is a balloon thathas an adjustable OD beyond its formed OD and will return to or verynear to its formed OD after having been adjusted to its maximum OD.Often compliant balloons have a narrower range of adjustment thanelastic balloons. Practical compliant balloons made of non-elastomericpolymers, such as nylon, Pebax and polyethylene, are more likely torequire a formed ID greater than the OD of the catheter that they aremounted on than practical elastic balloons made of elastomeric polymerssuch as silicone, latex and polyurethane. Thus, a design of anintegrated controlled volume inflation-deflation device may be selectedfor use with a certain type of initial inflation of a balloon. It isconsidered that device 1010 may initially inflate a balloon to itsnominal or desired OD using a selected volume of fluid. Integratedcontrolled volume inflation-deflation device 1010 may be aninflation-deflation device similar to inflation-deflation device 100including structure 400, 500, 800, or 900 as described herein.

Extension tube 1050 may be a pliable extension tube to connect betweenthe controlled volume inflation-deflation device and the stopcock, or toconnect between the controlled volume inflation-deflation device and thecatheter. Moreover, extension tube 1050 may be flexible, but has a lowcompliance, such that it doesn't exhibit a substantial change in thevolume within the extension tube lumen (e.g., a volume of fluid withinthe extension tube at zero pressure or at a pressure greater than zero)in response to bends, curves, or movement of the tube; grasping orholding the tube such as by a human hand, or pressure changes within thetube (e.g., pressure changes in a fluid within the tube).

Extension tube 1050 may have inner diameter D1 sufficient to communicatefluid between tip 1016 of syringe tube 1012 and input adapter 1042 ofcatheter 1040 via stopcock 1030 to cause a volume of fluid to inflateballoon 1048 to occlude a blood vessel at a region of interest.Moreover, extension tube 1050 may have inner material M1 and outermaterial M2 formed over inner material M1, such as by having outermaterial M2 surrounding and/or extruded over inner material M1. It isalso contemplated that material M1 and material M2 may be miscible, andmay be extruded to be miscible in an extrusion or co-extrusion process.In some examples, tube 1050 is formed by co-extruding miscible materialsM1 and M2 so that material M2 bonds with material M1 before material M1dries, sets, solidifies, and/or cools during the co-extrusion.

It can be appreciated that an extrusion or co-extrusion process mayinclude heating one or more volumes of materials to a melting point andextruding the materials out of an aperture or orifice over an airpressure line or tube. Thus, material M1 and material M2 may dissolveinto each other, be chemically miscible, and/or have a boundarytherebetween including a depth of atoms that are a mixture of materialM1 and material M2. Specifically, for example, a co-extrusion processmay include simultaneously extruding a tube of the inner material and atube of the outer material onto or over the first material so that thematerials form a miscible interface of the first material and the secondmaterial therebetween. Such co-extrusion may use a single “extruder” ordevice having two chambers that heat a volume of the first material anda volume of the second material to a melting point, and then extrude thefirst material and the second material over the first material over apressurized air opening of a tube or over a mandrel of an extrusion die.For instance, the extruder may use a screw mechanism or pressure devicein each chamber to force the melted materials out of two apertures ororifices in a die chamber to extrude the material out of the die openingover a hollow mandrel with pressurized air feeding it ID.

In other embodiments, where materials M1 and M2 are not miscible witheach other, an adhesive polymer (e.g., intermediate polymer) may beextruded between them to bond them together in a tri-layer co-extrusionprocess. In other embodiments, other conventional processes are used tobond/bind together the interface of materials M1 and M2. In otherembodiments, the interface of materials M1 and M2 is not bonded or boundtogether and special connectors are used that provide bonding surfacesfor each of the tubes made of materials M1 and M2.

FIG. 10 shows extension tube 1050 having inner diameter D1 and outerdiameter D2. In one example, diameter D1 (an inner diameter) is lessthan or equal to 0.035 inches and diameter D2 (an outer diameter) isgreater than or equal to 0.13 inches. It is contemplated that the wallthickness of material M1 may be 0.015 inches or less. However, there canbe considerable variation in the D1, D2 and wall thicknesses that may bechosen, depending upon M1 and M2 material properties and still produce atube with acceptable flexibility and acceptable low compliance.Furthermore, inner material M1 may be a polymer/plastic, preferably arelatively high modulus translucent material such as nylon or HDPE.Also, outer material M2 may be a polymer/plastic, preferably arelatively low modulus translucent material that is miscible withmaterial M1, such as Pebax or LDPE, respectively. The high modulus innerportion of the tube 1050 (material M1) provides the low compliance/lowvolume change properties of tube 1050. The low modulus outer portion(material M2) of the tube 1050 provides support to the inner portion toprovide kink resistance and may be used to increase the tube 1050 OD tothe OD of conventional extension tubes for tube 1050 compatibility withconventional extension tubing connectors, such as connectors 1054 and1056, while maintaining an acceptable level of flexibility. Moreover, itis preferred that materials M1 and M2 be bonded together, either by abonding agent or due to their being miscible, to facilitate theattachment of conventional connectors. Thus, extension tube 1050 may bea flexible tube that does not encounter significant volume changeswithin tube 1050 when flexing, bending, or being grasped, pushed, orheld by a human hand or in response to pressure changes within its ID.Also, material, thicknesses, and diameters of extension tube 1050 may beselected so that tube 1050 resists kinking, has a lower complianceand/or is more flexible than a tube made entirely of any single materialat any given D1 and D2. Moreover, material M1 and M2 may be translucentmaterials so that air bubbles are visible within extension tube 1050 tofacilitate ensuring that air is removed from the system.

Balloon 1048 (in a deflated and/or folded condition) and catheter 1040have a dimension suitable for percutaneous advancement through a bloodvessel, such as to a region of interest. Moreover, balloon 1048 has aproperty such that it may inflate to an outer diameter that will occludea blood vessel at a region of interest when it is inflated with aninflation volume, and may be deflated to perfuse blood to the bloodvessel when it is deflated to a deflation volume.

Aspiration syringe 1020 is shown having volume AVOL filled with fluidFL. Typically, aspiration is best done by a syringe that has no air init to begin with. After the aspiration, the syringe may have the airfrom the balloon/catheter in it. For more details, see description belowabout the details of aspiration. Volume AVOL is a volume sufficient toaspirate catheter 1040 and balloon 1048, such as to remove air fromspaces therein and fill those spaces with a liquid/fluid from theaspiration syringe 1020.

Stopcock 1030 includes position lever 1032 which may be switched betweenposition P1 and position P2. For example, when position lever 1032 is inposition P1, flow may be prohibited between extension tube 1050 andstopcock 1030. Thus, aspiration syringe 1020 may be used to aspiratecatheter 1040 and balloon 1048 when lever 1032 is in position P1. Whenlever 1032 is in position P2, flow may be blocked between aspirationsyringe 1020 and stopcock 1030. Thus, aspiration syringe 1020 may beremoved from stopcock 1030 when lever 1032 is in position P2 without aflow of air or liquid escaping from or entering stopcock 1030.

Moreover, volume AVOL and a seal between plunger 1022 and the sidewallof aspiration syringe 1020 may be sufficient to aspirate catheter 1040and balloon 1048, such as for volume AVOL to be filled with a minimalpressure or volume of air (e.g., such as close to 0 PSI of liquid andfew bubbles of gas in the liquid). The ability to aspirate as describedbelow allows balloon 1048 and communicating lumens to be filled withfluid and very little air, such as before, during or after insertion ofballoon 1048 percutaneously through a blood vessel to a region ofinterest. Moreover, system 1000 allows aspiration syringe 1020 to beremoved from detachable connector 1024 of stopcock 1030 after catheter1040 and balloon 1048 are aspirated and filled with a liquid.

According to some embodiments, during an aspiration process the balloonon the catheter is folded/deflated before and during the aspirationprocess. If not, it may immediately become deflated and stays deflatedduring the aspiration process. In use, the syringe 1020 is filled with asmall amount of fluid and very little or no air. To begin theaspiration, the syringe plunger is withdrawn. This withdrawal creates aspace between the fluid in the syringe and the plunger, which has verylittle, if any air in it and now has a very low pressure. It isimportant that no air slips past the plunger and enters the syringe, asthis will cause a loss of the low pressure (the pressure inside thesyringe will increase). The created low pressure in the syringe is feltby the air in the catheter's balloon inflation lumen and inside theballoon, which causes the air to expand. As this air expands, it hasnowhere to go but to bubble up through the fluid in the syringe and intothe empty space AR between the top of the fluid and the syringe plunger.The lower the pressure in the syringe/the further the syringe plunger iswithdrawn, the more this air expands and the more of the air insidecatheter/balloon bubbles up into the syringe. The air bubbling into thesyringe causes the pressure inside the syringe to rise. Once the airremaining in the catheter's balloon inflation lumen and inside theballoon reaches nearly the same pressure as the pressure inside thesyringe, the bubbles stop coming into the syringe, the syringe isflicked with the finger to ensure that only fluid is at the bottom ofthe syringe (removes air bubbles from the fluid) and then the syringeplunger is allowed to advance in the syringe, raising the pressure inthe syringe until the pressure in the syringe is pretty much equalizedwith atmospheric pressure. This atmospheric pressure is felt by theremaining air in the catheter's balloon inflation lumen and inside theballoon, which causes the air in them to compress. As the remaining aircompresses, fluid from the syringe flows into the catheter's ballooninflation lumen and inside the balloon until the remaining air insidethe catheter/balloon reaches near atmospheric pressure and no longercontinues to occupy less and less volume. The syringe is removed fromthe stopcock, the air in the syringe (from catheter's balloon inflationlumen and inside the balloon) is removed, the syringe reattached to thestopcock and the process repeated one or more times to remove most ofthe air and replace it with fluid.

Aspiration may be used to remove air from the system because air maycause problems with controlled volume inflation system operation becauseit is so compressible. So, to prevent such problems, the systemcomponents can be filled with fluid and assembled in a manner thatensures that all or most of the air from the system components (e.g.stopcock, extension line, aspiration syringe, controlled volumeinflation-deflation device, and the like) and fluid air bubbles areremoved prior to connecting them to the catheter. Additionally, allconnections may be made with the mating connector surfaces wetted/filledwith fluid, as this ensures an air and fluid tight connection and avoidsair being introduced into the connectors during the connection process(a “wet connection” process). This ensures that air will not get intothe system during system assembly and air and fluid will not get out ofor into the system during balloon inflation and deflation. Without theseprocesses, the OD of the balloon may not be controlled in a predictablemanner. In some cases, system 1000 may be used when performing theprocess of FIG. 11.

Also, system 1000 may be used for aspirating the balloon and inflationlumen of catheter 1040 and then inflating the balloon to its nominal ODby moving the latch of device 1010 from a mid-latch position to aninflation latched position (e.g., a most distal position) and thenadjusting the balloon OD in increments until occlusion using theproximal knob of device 1010. The balloon may then be deflated by movingthe latch of device 1010 to its deflation latched position (e.g., a mostproximal position). Moreover, after inflation, the balloon may beinflated/deflated to control the occlusion at will. Syringe 1020 may beremoved from the stopcock after the aspiration once the stopcock's leveris turned to point at the syringe, cutting off the flow from the syringeand connecting device 1010 to catheter 1040's inflation lumen. In somecases, it is preferred that the aspiration be done once the balloon isin position in the body/vessel, otherwise the inflation system must bemoved along with the catheter during the insertion procedure, which isvery clumsy/somewhat impractical. Additionally, if the catheter/balloonis aspirated prior to insertion and balloon positioning (for example bya syringe), then “wet” connecting the integrated controlled volumeinflation-deflation device 1010 to the catheter's inflation lumen canresult in fluid being forced into the catheter 1040 and balloon 1048,causing the balloon 1048 to become partially inflated. Unless theoperator is going to immediately use the system to obtain an occlusion,this partial inflation can be considered to be a safety hazard that mayimpede vessel blood flow and engage the anatomy or other devices if thecatheter/balloon is re-positioned. Furthermore, the volume of fluid thatmay be forced into the catheter 1040 and balloon 1048 during the wetconnection process is unpredictable, as it is dependent upon the amountconnection wetting/amount of fluid present in the connections and thespeed of their connection. When using an integrated controlled volumeinflation-deflation device like device 1010, which initially inflatesthe balloon 1048 by injecting a predetermined volume of fluid, thisvariable volume can introduce an undesirable balloon 1048 ODuncertainty. If the catheter/balloon is aspirated using the system shownin FIG. 10 when the balloon 1048 is in the occlusion position in thevessel, the wet connection between the stopcock 1030 and the catheter1040 occurs with the catheter/balloon filled with very compressible air.Thus, the air compresses as the small amount of wet connection fluid isforced into the catheter's inflation lumen, producing a very smallpressure rise in the balloon that is not a high enough pressure topartially inflate the balloon. Then, when the inflation system isconnected to the balloon inflation lumen of the catheter and thecatheter/balloon is aspirated, there is no extra or variable fluidvolume introduced into the system and the balloon is left in thedeflated condition. Thus, using an inflation system such shown in FIG.10 encourages the user to naturally follow a procedure that aspiratesthe catheter/balloon once the balloon is in the occlusion position inthe vessel and, thus avoid potential safety issues and balloon ODuncertainties.

Furthermore, an example process for using system 1000 in FIG. 10, or alike system, is described by the following operations:

-   1. The integrated controlled volume inflation-deflation device 1010    is attached to extension tube 1050 (wet connected) and they are    filled with contrast solution such that no bubbles or air voids are    present. This is done by placing or attaching the end of the    extension tube 1050 in or onto a contrast solution source and    pulling the device 1010 into its deflation position to pull contrast    solution into it. The device 1010 may then be pointed up and    transitioned (pushed together) to its inflation position to push the    air out of the syringe tube 1012 and extension line 1050. This may    involve hitting the device 1010 into your hand to dislodge bubbles,    additional transitions of the deflation/inflation positions and the    pulling in of more contrast solution. The device 1010 is left in a    mid-latched position appropriate for the vessel, balloon 1048 and    catheter 1040.-   2. The aspiration syringe 1020 (20 ml) is filled with about 4-5 ml    of dilute contrast media and de-bubbled.-   3. The catheter 1040 is positioned in the patient's coronary artery    or other vessel of interest and the balloon 1048 is positioned at    the desired occlusion position.-   4. The aspiration syringe 1020 is wet connected to the stopcock    1030.-   5. Using the fluid in the aspiration syringe 1020 and manipulating    lever 1032, the stopcock 1030 is filled with fluid and wet connected    to the extension tube 1050, leaving the stopcock lever 1032 in    position P1.-   6. The stopcock 1030 is wet connected to the catheter's balloon    inflation lumen proximal connection input adapter 1042 with the    stopcock lever 1032 in the position shown.-   7. The aspiration syringe 1020 is used to two times aspirate the    catheter as per the standard balloon catheter aspiration practice.-   8. The lever 1032 on the stopcock 1030 is rotated 90°    counterclockwise to position P2 and aspiration syringe 1020 is    removed.-   9. The device 1010 is transitioned from its mid-latched position to    its inflation position and the balloon 1048 is initially inflated to    the pre-determined volume (and OD).-   10. If applicable, the incremental inflation knob may be adjusted as    per a chart (click or counter number to balloon 1048 OD chart) and    previous vessel sizing (e.g. by fluoroscopy) to inflate the balloon    to a safe OD.-   11. The occlusion is tested, such as by contrast injections (e.g.,    via a guide catheter) or pressure readings (e.g., via a catheter    1040 lumen, a catheter 1040 infusion lumen).-   12. If the desired occlusion is not attained, the inflation knob is    incremented to increase the balloon 1048 OD.-   13. Operations 11 and 12 are repeated until vessel occlusion is    attained.-   14. The integrated controlled volume inflation-deflation device is    pulled apart into its deflation position to remove the vessel    occlusion and allow blood flow.-   15. The integrated controlled volume inflation-deflation device 1010    may then be transitioned between its inflation and deflation    positions to occlude the vessel for the desired amount time(s) at    the desired times as per the medical treatment or procedure    protocol.-   16. With the balloon 1048 deflated by the integrated controlled    volume inflation-deflation device 1010 in its deflation latched    position, the catheter may be re-positioned in the vessel or removed    from the vessel.-   17. The incremental inflation knob is adjusted as per the click to    OD chart to a safe initial OD for the new vessel position or back to    its initial position (e.g., zero).-   18. The integrated controlled volume inflation-deflation device 1010    is transitioned to its inflation latched position and the    incremental inflation knob is adjusted as previously described in    operations 11-13 to attain vessel occlusion.-   19. The integrated controlled volume inflation-deflation device 1010    is pulled apart into its deflation latched position to remove the    vessel occlusion and allow blood flow.-   20. The integrated controlled volume inflation-deflation device 1010    may then be transitioned between its inflation and deflation    positions to occlude the vessel for the desired amount time(s) at    the desired times as per the medical treatment or procedure    protocol.-   21. Operations 16 thru 20 may be repeated, as necessary.-   22. With the balloon 1048 deflated by the integrated controlled    volume inflation-deflation device, the stopcock 1030 may be removed    from the catheter 1040 and the catheter 1040 withdrawn from the    patient.-   23. If the integrated controlled volume inflation-deflation device    1010 is to be re-used with a different catheter in the same patient,    then the device must be returned to its initial (out of package)    adjustment conditions and operations started again beginning with    operation 1.

It is contemplated that operations in addition to those above may beperformed when using system 1000 or a like system. Also, in some cases,fewer than all of the operations above may be performed when usingsystem 1000 or a like system. Likewise, in some cases, the order of someof the operations above may be switched around when using system 1000 ora like system.

FIG. 7A is a schematic cross-sectional side view of a cowling and a viewof a distal housing of an integrated controlled volumeinflation-deflation device that performs the initial balloon inflationusing a pre-determined pressure. Distal housing 720 and cowling 780 bothhave longitudinal axis LAX. Distal housing 720 has threads 781 on theouter surface of its proximal end. Distal housing 720 has distal housinginternal features similar to those described above with respect tohousing 220 to retain a syringe tube (not shown). Distal housing 720 hasa cutout 730 to allow the syringe tube (not shown) to be viewed to aidensuring that air bubbles are removed. In other embodiments, alternatelyor in addition, the distal housing 720 or parts of the distal housing720 may be made of a translucent material for this same purpose. Distalhousing 720 has mounting feature 731 near its distal end to support apressure gauge (not shown) or parts of a pressure gauge (not shown) thatcommunicates with the output of the syringe tube (not shown) to providea readout of the inflation pressure. Distal housing 720 includesindexing locks 758 and 759. Cowling 780 has recesses 782 and 786.Recesses 782 and 786 may correspond to recesses 482 and 486 as describedabove in FIG. 4. Cowling 780 has slot 787 circumferentially disposedaround its ID. In addition, slot 787 has gear teeth-like or other indentfeatures 789 on its inner surface. Cowling 780 has threads 788 on itsID.

FIG. 7B shows distal housing 720 attached to cowling 780 by pressureinflation adjustment and releasable latch mechanism 710. Cowling 780 isthreadably attached to distal housing 720 via thread 788 along its innersurface engaging with threads 781 along the proximal outer surface ofthe distal housing 720. Cowling 780 is constrained in its distal motionrelative to distal housing 720 by the engagement of indexing locks 758and 759 with the proximal surface 791 of slot 787 and constrained in itsproximal motion relative to distal housing 720 by the engagement ofindexing locks 758 and 759 with the distal surface 792 of slot 787. Inother embodiments, alternatively or in addition, the distal motion ofcowling 780 relative to distal housing 720 may be constrained by thelength of threads 781 and/or 788 and/or the interference of the proximalend of distal housing 720 with an inner surface 725 of cowling 780.Indexing locks 758 and 759 engages gear teeth-like or other indentfeatures 789 of slot 787 such that an applied rotational force isrequired to rotate the cowl 780 relative to distal housing 720 andduring rotation, indexing locks 758 and 759 engage gear teeth-like orother indent features 789 in a manner that provides multiple stablereleasably latched/locked rotational relationships between the cowling780 and the distal housing 720.

Thus, pressure inflation adjustment and releasable latch mechanism 710may include threads 781 and 788 to adjust or move cowling 780 alonglength LEN with respect to distal housing 720. Similar to the discussionabove with respect to structure 400 and FIG. 4, structure 700 may beused as part of an integrated controlled volume inflation-deflationdevice, such as by replacing distal housing 120 and cowling 180 of FIGS.1A, 2 and 3. For example, a latch may be formed between locks 152 and154 and recesses 782 and 786. Locks 152 and 154 engaging recesses 782and 786 may correspond to inflation (first) latched position and thedeflation (second) latched positions previously described with respectto structure 400 of FIG. 4. Additionally, cowling 780 may containthreaded holes 726 and 727 to engage retaining pins 160 and 162 and thusmaintain the position of locks 152 and 154 relative to recess 786 whenthe integrated controlled volume inflation-deflation device is in thesecond latched (deflation) position. Thus, FIG. 7 is an example of anembodiment where retaining pins are attached to the cowling (e.g., atthreaded holes 726 and 727) and extending through a portion of theproximal housing to engage a stop surface of the proximal housing. Inother embodiments, it is contemplated that cowling 780 may be providedwith a mid-position latching recess(es) such as those previouslydescribed in reference to FIG. 5. In those embodiments, the integratedcontrolled volume inflation-deflation device may either initiallyinflate a balloon(s) using a pre-determined volume(s) of fluid orinitially inflate a balloon(s) using a pre-determined inflationpressure.

It can be appreciated that by rotating cowling 780 in rotationaldirections ROT with respect to distal housing 720 along longitudinalaxis LAX, the position of plunger 110 of such a controlled volumeinflation-deflation device may be moved along distance L of syringe tube112 while indexing locks 152 and 154 engage recess 782 in the inflation(first) latched position. Thus, when indexing locks 152 and 154 engagerecess 782, threads 781 and threads 724 may be corresponding threadssufficient in number and spacing and rotated relative to each other tomove plunger 110 to push a volume of fluid into an occlusion balloonuntil the pre-determine initial inflation pressure is attained, asindicated on the readout of the pressure gauge (not shown), such asafter the balloon is aspirated and advanced through a blood vessel suchas is described above with respect to FIGS. 5 and 6. Specifically,threads 781 and threads 788 allow structure 700 to provide adjustablevolumes of fluid to inflate to a pre-determined pressure various balloonsizes, materials, structures, and designs after inserting any one of thevarious balloons into a blood vessel and to a region of interest.Cowling 780 also includes a stop 790 similar to stop 490 of FIG. 4 and aproximal end 755 similar to proximal end 455 of FIG. 4. Because stop 790is a part of cowling 780, the translation of cowling 780 relative to thedistal housing 720 (due to the previously described rotation) will notaffect the amount of the volume change within the syringe (not shown)when the integrated controlled volume inflation-deflation device istransitioned between the inflation and deflation latched positions.

According to some embodiments, a system may be used to aspirate as wellas to inflate and deflate an occlusion balloon which includes anintegrated controlled volume inflation-deflation device with a distalhousing and cowling as described in reference to FIGS. 7A and 7B. Forexample, FIG. 12 is a schematic side view of one embodiment of aninflation system including a partial see through side view of anintegrated controlled volume inflation-deflation device that performsthe initial inflation of a balloon using a pre-determined inflationpressure attached to a catheter having a balloon at its distal end and aview of the aspiration syringe. In FIG. 12, integrated controlled volumeinflation-deflation device 1310 may have a distal housing similar todistal housing 720 and a cowling similar to cowling 780. Device 1310 ispart of inflation system 1300. FIG. 12 shows an integrated controlledvolume inflation-deflation device 1310 attached to an extension tube1050 that is attached to a catheter 1040 having a balloon 1048 at itsdistal end and an aspiration syringe 1320 for aspirating the balloon andcatheter. FIG. 12 shows system 1300 having aspiration syringe 1320(e.g., a 20 milliliter aspiration syringe). System 1300 also includesinflation-deflation device 1310 (e.g., an integrated controlled volumeinflation-deflation device or “CV1”) attached to or connected toextension tube 1050, which is attached to catheter 1040 (e.g., a balloonocclusion catheter) having balloon 1048 attached at or near distal end1046. Thus, extension tube 1050 may be attached and sealed (e.g., suchas to form a fluid and air tight seal) to inflation-deflation device)310 and catheter 1040.

Similar to integrated inflation-deflation device 1010 of FIG. 10, device1310 of FIG. 12 may be described as an “integrated” inflation-deflationdevice, since device 1310 may not require assistance from anotherinflation-deflation device (e.g., In FIG. 14 low volume syringe or lowpressure inflation-deflation device 1420) to conveniently initiallyinflate an occlusion balloon to an initial or formed OD from a folded orminimal OD. Once the balloon 1048 is inflated to its initial OD using apre-determined pressure, device 1310 is able to inflate the balloon toan occlusion OD sufficient to occlude a blood vessel, to deflate theballoon to a sufficient OD to allow the balloon to be advanced orwithdrawn within a blood vessel, or to allow perfusion of a blood vesseland then to subsequently re-inflate the balloon to the set occlusion ODand deflate the balloon at will.

Also, according to some embodiments, controlled volumeinflation-deflation device 1310 may be an inflation-deflation devicehaving structure 100, 200, 400, 500, or 600 as described herein, exceptthat device 1310 includes pressure gauge 1314 and pressure inflationadjustment and releasable latch mechanism 1315. Also, pressure inflationadjustment and releasable latch mechanism 1315 may include the pressureinflation adjustment and releasable latch mechanism 710 as described inFIGS. 7A and 7B. Moreover, inflation-deflation device 1310 may includeincremental inflation knob 1333 such as knob 130.

In some embodiments, device 1310, which may be used with compliantballoons and with balloons with a formed ID larger than the OD of thecatheter shaft on which the balloon is mounted, the balloon is inflatedto its initial or formed diameter by forcing fluid into the balloon at alow pressure and then using controlled increments of injected fluid toadjust its OD until occlusion (e.g., such as using device 100, and/orthe processes for FIG. 11). Device 1310 can then be transitioned fromthe first latched (inflation) position to the second latched (deflation)position to deflate the balloon and allow perfusion of the vessel. Thenit can be transitioned between the second latched (deflation) positionand the first latched (inflation) position to inflate the balloon backto that occlusion OD and occlude the vessel (stop blood flow) or deflatethe balloon (allow blood flow) at will.

When device 1310 is in the first (inflation) latched position, rotationin one direction of the pressure inflation adjustment and releasablelatch mechanism 1315 will cause the proximal portion of device 1310 tomove toward the distal portion of device 1310. This motion causes theplunger of the syringe (constrained by the proximal portion of device1310) to move further into the syringe body (constrained by the distalportion of device 1310) and, thus, forces fluid out of the syringe ofdevice 1310 and into the catheter or lumen to inflate the balloon.

When the balloon has been inflated in this manner to its initial orformed diameter at a low pressure, the rotational position of thepressure inflation adjustment and releasable latch mechanism 1315 islocked relative to the distal housing. To allow the device to bere-adjusted or re-used during a procedure, this locking or latchingmechanism is preferred to be releasable. One mechanism is described aspart of pressure inflation adjustment and releasable latch mechanism 710in FIG. 7. There are many conventional releasable locking mechanismsthat can be employed. For example, the threaded portion of the distalend of the cowling may be longitudinally slotted and its OD threaded onan incline. These OD threads can then be engaged with new threadedcylinder. Thus, when this new cylinder is engaged with the new ODthreads and further rotated, the incline causes the threads of the newproximal portion of the distal housing to be increasingly forced againstits mating threads on the modified distal portion of the distal housing.The resulting friction will prevent any unintentional rotation. Rotatingthe new threaded cylinder in the other direction will release thethreads and allow a further or a new adjustment.

Once these threads are locked, the knob 1333 on the proximal portion ofdevice 1310 may be incremented to move the syringe plunger inlongitudinal increments to incrementally force additional fluid into theballoon to adjust its diameter in the previously described manner. Theballoon may also be deflated and re-inflated by transitioning device1310 between its first (inflation) and second (deflation) latchingpositions in the normal manner.

Device 1310 may thus be attached to occlusion catheter/device the samemanner as shown in FIG. 10. The catheter aspiration and stopcockmanipulation procedures may also be the same (e.g., may include theprocess of FIG. 11). Alternatively, device 1310 (or device 1010 in FIG.10) may be directly attached or preferably attached via an extensiontube/line to an aspirated catheter. It is conventional for an extensionline/tube, with appropriate Luer type connectors, to be a permanent partof the construction of an inflation-deflation device and such may be thecase for all controlled volume inflation-deflation devices describedherein. It is preferred that the extension tube/line be a low compliancetype, as previously described.

According to some embodiments, gauge 1314 may be a low compliance type(like many electronic pressure gauges) and that its communication withthe syringe's output flow path be such that air will not be trapped init, as trapped air will also increase device compliance. Devicecompliance and differences in compliance between devices introducesballoon size (OD) variability with the same injected fluid volume. Themore compliance in the inflation system, the more injected fluid volumeis required to produce the same balloon size (OD) change. Suchvariability in the control of an occlusion balloon's OD is undesirabledue to safety and ease of use considerations.

More particularly, in some embodiments gauge 1314 may be a lowcompliance type electronic pressure gauge. FIG. 13 shows device 1360having syringe 1370, which is attached to an extension tube/line 1050which may be attached to a catheter having an occlusion balloon. Forinstance, device 1360 can be used in place of variousinflation-deflation devices described herein and is most similar to thedevices described in relation to FIGS. 7A, 7B and 12. Components ofdevice 1360 may be similar to their corresponding components of device100, 200, 1310; and/or devices including structure 400, 500, 700, and800. Device 1360 may be described as an “integrated” inflation-deflationdevice.

As shown in FIG. 13, inflation-deflation device 1360 includes pressuretransducer 1364 located between syringe 1370 and extension line 1050.The electrical wires to/from the pressure transducer may run down thearm 1366 to oblong part 1371 of device 1360. The oblong part of device1360 may house the electronics and the battery for pressure transducer1364 and a pressure reading display. The oblong part 1371 of device 1360may have a cut-out 1368 in it that represents the display which willindicate the pressure reading. On the opposite side of the oblong part1371 of device 1360 can include button 1369 that must be pushed tounlock the syringe (outer body) position during the pressure adjustment.Knurled knob 1372 between syringe 1370 and oblong portion 1371 is turnedto adjust the pressure of the balloon during the initial inflation (bymoving the outer body of the syringe 1370) when the button is pushed.Part 1380 of device 1360 proximal of the oblong portion 1371 may be likethe portions of a non-integrated inflation-deflation device (e.g.,device 100 or 1410) that has the inflation and deflation releasablylocked positions and proximal knob 1383 for incrementalinflation/balloon OD adjustment.

For either device 1310 or 1360, if the pressure gauge is a highcompliance type (like most mechanical pressure gauges), then thecommunicating flow path between the syringe output and the pressuregauge is preferred to be turned off after the balloon is initiallyinflated to a low pressure and before the incremental adjustment of theballoon's OD. Thus, in this embodiment, a shut-off valve is may beincorporated, preferably on the distal portion of device 1310. However,if the operator/physician were to forget to close this valve, then theballoon OD may not increment as expected and may fail to be able to beadjusted enough to successfully occlude the vessel or as expected. Tosolve this problem, a mechanism such as a spring loaded shaft may beincorporated in device 1310 such that it interferes with thelongitudinal incremental manipulation mechanism and will not allow it tooperate. When the valve is turned to shut off the pressure gauge, theshaft is released by a portion of the valve lever/stem and the springmoves the shaft out of the longitudinal incremental manipulationmechanism, allowing it to operate. If device 1310 is to be later re-usedin the procedure, the longitudinal incremental manipulation mechanismmay be returned to its starting position (i.e. increment count “0”), theshaft forced back into the longitudinal incremental manipulationmechanism and the valve opened, which retains the spring loaded shaft'sposition. Thus, device 1310 may be returned to it initial condition andis ready for re-use (the pressure inflation adjustment and releasablelatch mechanism may also be turned back to its original startingposition).

According to some embodiments, inflation-deflation devices may include ascrew mechanism (e.g., knob 1373 and/or 1383) coupling a housing (e.g.,housing 140 or housing 120) to a plunger (e.g., plunger 110) or syringetube with the plunger disposed within the syringe tube (e.g., tube 112)to move the plunger along a length of the tube, where the screwmechanism is attached to one of the proximal housing, and the distalhousing. Specifically, the distal housing may include a screw mechanismcoupled to a syringe tube with a plunger disposed within the syringetube to move the plunger along a length of the syringe tube. Similarly,Specifically, the proximal housing may include a screw mechanism coupledto a syringe tube with a plunger disposed within the syringe tube tomove the plunger along a length of the syringe tube. In some cases both,the distal and proximal housings may include such a screw mechanism. Forexample, referring to FIG. 13, in some embodiments, knob 1372 on thedistal housing (oblong housing 1371) may be used to adjust the positionof the syringe tube via a screw mechanism; and knob 1383 and anotherscrew mechanism in the proximal housing may be used to adjust theposition of the plunger, so FIG. 13 achieves plunger positions similarto those discussed in reference to FIG. 12.

Furthermore, an example process for using system 1300 and/or device1360, or a like system or device, is described by the followingoperations:

-   1. The integrated controlled volume inflation-deflation device 1310    or 1360 is filled with contrast solution such that no bubbles or air    voids are present. This done by placing or attaching the end of the    extension line 1050 in or onto a contrast solution source and    pulling the device 1310 or 1360 into its deflation position to pull    contrast solution into it. The device 1310 or 1360 may then be    pointed up and transitioned (pushed together) to its inflation    position to push the air out of the device 1310 syringe and    extension line 1050. This may involve hitting the device 1310 or    1360 into your hand to dislodge bubbles, additional transitions of    the deflation/inflation positions and the pulling in of more    contrast solution. The device 1310 or 1360 is left in the inflation    position.-   2. The aspiration syringe 1320 (20 ml) is filled with about 3-4 ml    of dilute contrast media and de-bubbled.-   3. The aspiration syringe 1320 is wet connected to the catheter's    balloon inflation lumen connection and used to directly two times    aspirate the catheter and balloon 1048 prior to its insertion into    the patient as per the standard balloon catheter aspiration    practice.-   4. The aspiration syringe 1320 is removed. The balloon inflation    connection on the catheter is left filled with contrast solution    when the aspiration syringe is removed.-   5. The catheter 1040 is positioned in the patient's coronary artery    or other vessel of interest and the balloon 1048 is positioned at    the desired occlusion position.-   6. The integrated controlled volume inflation-deflation device 1310    or 1360 is wet connected to the catheter 1040. If operation 7 is not    to be immediately performed, the pressure inflation adjustment on    the integrated controlled volume inflation-deflation device 1310 or    1360 is unlocked/unlatched/rotated such that balloon deflation is    assured (e.g., a small negative pressure) and re-locked/left    releasably latched.-   7. The pressure inflation adjustment on the integrated controlled    volume inflation-deflation device 1310 or 1360 is    unlocked/unlatched/rotated and the catheter's balloon 1048 is    initially inflated to the pre-determined low pressure (e.g., 0.5    ATM).-   8. The pressure inflation adjustment on the integrated controlled    volume inflation-deflation device 1310 or 1360 is locked/left in a    releasably latched state. (Note: It is assumed that the pressure    gauge is a suitably low-compliance type, otherwise there could need    to be operations to cut the pressure gauge out of fluid    communication with the inflation lumen and, in some embodiments, to    unlock the incremental inflation knob.)-   9. If applicable, the incremental inflation knob 1333 may be    adjusted as per a chart (click or counter number to balloon 1048 OD    chart) and previous vessel sizing (e.g. by fluoroscopy) to inflate    the balloon 1048 to a safe OD.-   10. The occlusion is tested, such as by contrast injections (e.g.,    via a guide catheter) or pressure readings (e.g., via a catheter    1040 lumen, a catheter 1040 infusion lumen).-   11. If the desired occlusion is not attained, the inflation knob    1333 is incremented to increase the balloon 1048 OD.-   12. Operations 10 and 11 are repeated until vessel occlusion is    attained.-   13. The integrated controlled volume inflation-deflation device 1310    or 1360 is pulled apart into its deflation position to remove the    vessel occlusion and allow blood flow.-   14. The integrated controlled volume inflation-deflation device 1310    or 1360 may then be transitioned between its inflation and deflation    positions to occlude the vessel for the desired amount time(s) at    the desired times as per the medical treatment or procedure    protocol.-   15. With the balloon deflated by the integrated controlled volume    inflation-deflation device 1310 or 1360 in its deflation position,    the catheter 1040 may be re-positioned in the vessel or removed from    the vessel.-   16. The incremental inflation knob 1333 is adjusted as per the click    to OD chart to a safe initial balloon 1048 OD for the new vessel    position or back to its initial position (e.g., zero).-   17. The integrated controlled volume inflation-deflation device 1310    or 1360 is transitioned to its inflation position and the    incremental inflation knob 1333 is adjusted as previously described    in operations 10-12 to attain vessel occlusion.-   18. The integrated controlled volume inflation-deflation device 1310    or 1360 is pulled apart into its deflation position to remove the    vessel occlusion and allow blood flow.-   19. The integrated controlled volume inflation-deflation device 1310    or 1360 may then be transitioned between its inflation and deflation    positions to occlude the vessel for the desired amount time(s) at    the desired times as per the medical treatment or procedure    protocol.-   20. Operations 15 thru 19 may be repeated, as necessary.-   21. With the balloon 1048 deflated by the integrated controlled    volume inflation-deflation device 1310 or 1360 in the deflation    position, the integrated controlled volume inflation-deflation    device 1310 or 1360 may be removed from the catheter 1040 and the    catheter 1040 withdrawn from the patient.-   22. If the integrated controlled volume inflation-deflation device    1310 or 1360 is to be re-used with a different catheter in the same    patient, then the device must be returned to its initial (out of    package) adjustment conditions and operations started again    beginning with operation 1.

It is contemplated that operations in addition to those above may beperformed when using system 1300 and/or device 1360, or a like system ordevice. Also, in some cases, fewer than all of the operations above maybe performed when using system 1300 and/or device 1360, or a like systemor device. Likewise, in some cases, the order of some of the operationsabove may be switched around when using system 1300 and/or device 1360,or a like system or device. Moreover, according to some embodiments, theoperations above may include those described with respect to theprocesses of FIG. 11.

Moreover, according to some embodiments, a device similar to device 1310or 1360 may be used to obtain the initial occlusion, as well as toinflate and deflate an occlusion balloon, where the balloon is initiallyinflated (e.g., to a nominal OD) using a pre-determined injectionvolume. The example process described above for using system 1300 and/ordevice 1360 may be applicable to integrated controlled volumeinflation-deflation device embodiments with features described inreference to FIGS. 5, 6, 8 and 10 by replacing operations requiringleaving the controlled volume inflation-deflation device in theinflation position prior to an initial balloon inflation with leavingthe device in an appropriate mid-latched position and replacingoperations requiring a predetermined pressure with operations requiringa an initial balloon inflation with a predetermined volume, such as aselected volume to provide an initial inflation to a formed or desireddiameter by transitioning the device from a mid-latched position to theinflation latched position.

FIG. 11 is a flow diagram of a process to occlude, treat, and perfuse ablood vessel. FIG. 11 may be a process that includes operations of theprocesses described above for using an inflation-deflation device, suchas inflation-deflation device 100 or 200 or an inflation-deflationdevice including structure 400, 500, 700, 800, 900, 1010, 1310, 1410,system 1300, 1360, 1400, and/or otherwise as described herein. At block1105, a cannula having a balloon attached at or adjacent its distal end(e.g., a cannula for advancing percutaneously through a blood vessel toa region of interest), and the balloon may be aspirated. Block 1105 maycorrespond to aspirating balloon 1048 and catheter 1040 as describedabove with respect to FIG. 10, such as using aspiration syringe 1020 andstopcock 1030. Also, block 1105 may correspond to an operation of theprocess described above for using system 1300, 1000, and/or 1400.

Next, at block 1110, the cannula and balloon are advanced to a region ofinterest in a blood vessel. Block 1110 may correspond to descriptionsabove with respect to advancing cannula 392, balloon 348, cannula 692,balloon 648, catheter 1040, and/or balloon 1048 to a region of interest.Also, block 1110 may correspond to an operation of the process describedabove for using system 1300, 1000, and/or 1400.

At block 1115, the balloon is inflated to its initial or beginningdiameter with a controlled volume or a controlled low pressure, byadvancing an inflation-deflation device's plunger relative to a syringebody (or vice versa). A controlled volume or a controlled low pressuremay be described as a selected or known volume or pressure. Block 1115may be applicable for setups using a non-integrated controlled volumeinflation-deflation device, such as inflation-deflation device, such asinflation-deflation device 100 or 200 or an inflation-deflation deviceincluding structure 400, 1410, system 1400, and/or otherwise asdescribed herein. For instance, a “non-integrated” device may requireassistance of another device to inflate a balloon to an initial orbeginning diameter and to inflate the balloon to an occlusion diameterto occlude a blood vessel. A “non-integrated” device may not be able toor may not be able to conveniently inflate a balloon to an initial orbeginning diameter and to inflate the balloon to an occlusion diameterwith a single plunger, but may instead require assistance from anotherdevice having another plunger, such as a conventionalinflation-deflation device, another syringe, and the like. With respectto the process of FIG. 11, in a non-integrated inflation system, theinflation device in 1115 may be a different inflation-deflation devicethan the one used in 1125, 1130,1140, and 1150. In an integratedinflation system, the inflation-deflation device may be the same in allsteps and there is only one plunger in the device. One plunger (versustwo or more in the device) can provide a key improvement over previousdevices, such as with respect to controlling the volume (or pressure) offluid used to inflate and/or deflate the balloon.

For example, block 1115 may correspond to adjusting the pressure orvolume inside the balloon and cannula to an initial or beginningpressure or volume as described above with respect to FIGS. 1-4 and/or14. Specifically, block 1115 may correspond to engaging recess 182 or282 with lock 152 or lock 252, respectively, as described above forFIGS. 1-3. Also, block 1115 may correspond to engaging recess 482 withlock 152 as described above for FIG. 4. Also, block 1115 may correspondto adjusting the pressure inside the balloon and cannula to an initialor beginning pressure using a low pressure inflation device, asdescribed above with respect to system 1400 of FIG. 14. Alternately,block 1115 may correspond to adjusting the volume inside the balloon toan initial or beginning volume using a low volume syringe, as alsodescribed above with respect to system 1400 of FIG. 14. For example,block 1115 may correspond to latch 150 being in position INFLAT as shownin FIG. 1A such as by pushing housing 140 and 120 together, such as byusing human hands. Moreover, with the non-integrated controlled volumeinflation-deflation device in the inflation latched position and as partof the inflation system 1400 as shown in FIG. 14, the occlusion balloon1448 may be inflated to an initial diameter using a controlled lowpressure or a controlled volume applied by another inflation device1420.

Alternatively, block 1115 may be applicable for setups using anintegrated controlled volume inflation-deflation device, such as aninflation-deflation device including structure 500, 700, 800, 900, 1010,system 1000, 1310, system 1300, 1360, and/or otherwise as describedherein for an “integrated” device. For instance, and integrated devicemay only use a single plunger to inflate a balloon to an initial orbeginning diameter and uses the same plunger to inflate the balloon toan occlusion diameter to occlude a blood vessel. Moreover, such anintegrated device may also use the same plunger to deflate the balloonto a perfusion or balloon relocation diameter, and may use the sameplunger to transition between the occlusion and perfusion diameters.

For example, block 1115 may correspond to adjusting the pressure orvolume inside the balloon and cannula to an initial or beginningpressure or volume as described above with respect to FIGS. 5-10, 12and/or 13. Specifically, block 1115 may correspond to adjusting thepressure inside the balloon and cannula to an initial or beginningpressure, as described above with respect to an inflation-deflationdevice including structure 700, 1310, system 1300, and/or 1360 of FIGS.7, 12 and 13. Moreover, block 1115 may correspond to adjusting thevolume inside the balloon and cannula to an initial or beginning volumeby transitioning the device from a mid-latched position to an inflationlatched position, as described above with respect to aninflation-deflation device including structure 500, 600, 800, 900,and/or 1010 of FIGS. 5, 6, 8, 9, and 10. For instance, block 1115 maycorrespond to lock 152 and/or lock 154 engaging recess 588, 864, or 992while the volume inside syringe body 112 is in communication with theballoon inflation lumen and balloon and then being transitioned toengaging recess 582, 862, or 982, respectively, of FIGS. 5, 6, 8 and 9as described above.

Additionally, according to some embodiments of either non-integrated orintegrated controlled volume inflation-deflation devices, block 1115 mayentail the incremental inflation of the balloon OD to a safe ODaccording to a chart relating the inflation increment to the expectedmaximum balloon OD either in place of an initial inflation with acontrolled volume of fluid or in addition to an initial inflation with acontrolled volume or pressure of fluid. Specifically, as described abovein reference to FIG. 3, the knob 130 of non-integrated device 100 may beturned a predetermined number of increments to initially inflate the ODof balloon 348 to a safe OD (e.g. a balloon OD that a measurement of theID of vessel 390 near region of interest 396 indicates is safe or aballoon OD that will not over-stretch the vessel 390). This may not be apreferred embodiment due to the large number of volume increments thatwould be required, as was described previously. Also, as described abovein reference to FIG. 14, the knob of non-integrated device 1410 may beturned a predetermined number of increments, after the initial inflationof balloon 1448 by either a controlled pressure or volume using anotherinflation device 1420, to further increase the balloon OD to a safe OD.Also, as described above in reference to FIG. 10, the knob of integrateddevice 1010 may be turned a predetermined number of increments, afterthe initial inflation of balloon 1048 by transitioning device 1010 froman appropriate mid-latch position to the inflation latched position, tofurther increase the OD of balloon 1048 to a safe OD. Also, as describedabove in reference to FIG. 12, the knob of integrated device 1310 may beturned a predetermined number of increments, after the initial inflationof balloon 1048 by adjusting pressure inflation adjustment and lockmechanism 1315 of device 1310, to further increase the OD of balloon1048 to a safe OD.

At block 1120 it is determined if the blood vessel is occluded. Block1120 may include use of imaging or contrast agent, pressure measurementand/or other processes as described herein, or as known in the art.

If at block 1120 the blood vessel is not occluded, the process of FIG.11 continues to block 1125. At block 1125, the diameter of the balloonis increased by injecting an additional controlled volume of fluid byadvancing the controlled volume inflation-deflation device's plunger.Specifically, block 1125 may include injecting a selected or knownvolume of liquid or fluid (e.g., substantially excluding gas or airbubbles) within the cannula and balloon. Also, at block 1125, theplunger of the inflation-deflation device may be pushed to a location tocause the balloon to occlude the blood vessel at a region of interest.In some cases, block 1125 may correspond to operations of the processdescribed above for using an inflation-deflation device, such asinflation-deflation device 100 or an inflation-deflation deviceincluding structure 200, 400, 500, 700, 800, 900, 1010, system 1000,1310, 1410, system 1300, 1360, system 1400, and/or otherwise asdescribed herein. For instance, block 1125 may include rotating knob130, 1333, or 1383 in rotational directions. For example, block 1125 mayinclude incrementally increasing the volume of fluid in the balloon withan incremental volume of fluid pushed into the balloon by a controlledvolume inflation-deflation device as described herein. For instance,block 1125 may correspond to the description above with respect tooccluding a blood vessel with balloon 348 of FIG. 3, and balloon 1048 ofFIG. 10. Thus, block 1125 may include twisting knob 130 in rotationaldirections ROTS until inflation-deflation device 100 in FIG. 3 haspushed an occlusion volume of fluid into balloon 348 to cause balloon348 to occlude a blood vessel. Thus, block 1125 may include rotatingknob 130 to inflate balloon 348 to have an inflation or outer diameterthat is at least equivalent to an inner diameter of blood vessel 390 atregion of interest 396 to occlude fluid or blood from moving by or pastballoon 348 in vessel 390 directions DIRS as shown in FIG. 3. Also,block 1125 may correspond to operations of the process described abovefor using system 1000, 1300, 1400, and/or device 1360. One or morevolume increments of fluid may be injected. The injected volumeincrements of fluid may or may not be sufficient to occlude the vessel.

After block 1125 processing returns to block 1120. If at block 1120 theblood vessel is not occluded, the process of FIG. 11 returns to block1125. If at block 1120 the blood vessel is occluded, the process of FIG.11 continues to block 1130. At block 1130 the controlled volumeinflation-deflation device is transitioned to the deflation latchedposition to withdraw the plunger and deflate the balloon and remove theocclusion (e.g., caused by the inflated balloon).

At block 1130, the plunger of the inflation-deflation device may beretracted to a location to allow perfusion of the region of interestwith blood. Block 1130, may include unlocking the latch, such as bypulling the distal housing away from the proximal housing of aninflation-deflation device, such as using human hands, to cause a latchto become unlocked to be subsequently locked in a deflation latchedposition. Specifically, block 1130 may correspond to pulling distalhousing 120 and proximal housing 140 apart to put latch 150 in positionDEFLAT as described above with respect to transitioning from FIG. 1A toFIG. 2 such that blood may flow in directions DIRS through vessel 390and by balloon 348 as shown in FIG. 3 (deflated balloon 348 not shown inFIG. 3). Block 1130 may also correspond to engaging recess 486, 586,786, or 986 with lock 152 and lock 154 as described for FIGS. 4-7 and 9.Moreover, block 1130 may correspond to engaging pin recess 866 with lock852 as described for FIG. 8. Also, block 1130 may correspond to anoperation of the process described above for using system 1000, 1300,1400, and/or device 1360.

Moreover, block 1130 may include transitioning the inflation-deflationdevice to a deflation latched position to withdraw the plunger anddeflate the balloon and remove the occlusion for a selected period oftime. In some cases, the balloon may be deflated to perfuse the bloodvessel for a reasonable time to avoid damage to the tissue fed ordrained by the vessel, such as by lack of oxygen (e.g., 1, 2, 3, 4, 5,10, 20, any combination thereof of minutes, or any number of seconds).For instance, block 1130 may involve pulling the distal housing and theproximal housing of the inflation-deflation device apart, such as usinghuman hands, to move plunger 110 towards the proximal end of theinflation-deflation device to withdraw a sufficient fluid from theocclusion balloon via the cannula or catheter's balloon inflation lumeninto syringe tube 112 to allow perfusion of the blood vessel for aselected period of time. For example, the selected period of time may bea desired time to allow blood flow, nutrients, and oxygen thereof to theregion of interest of the blood vessel between occlusion and/ortreatment periods. The performance of blocks 1115, 1120 and 1125 mayresult in a reduced vessel blood flow for a sufficient amount of timethat the tissues fed or drained by the vessel may require a more normalperfusion or it may be advantageous to perfuse the tissues for a periodof time. Additionally, it is expected for ease of use reasons that thefluid/injectate to be infused will not be connected to thecatheter/cannula during catheter/cannula placement and the subsequentadjustment of the balloon's diameter to obtain a safe occlusion. Thus,the time required to locate, prepare and connect the syringe or otherdevice containing the injectate to a catheter or cannula would also addto the time of reduced blood flow and occlusion and provide a time wherethe user could be distracted for an additional period of time.Therefore, it is expected that one safe process is to deflate theballoon and allow blood flow in the vessel for a period of time afterthe occlusion is attained and/or during fluid/injectate preparation andconnection to the catheter/cannula.

At block 1135 a treatment agent is connected to the cannula (or acatheter having a cannula for infusing treatment agent into a bloodvessel). Block 1135 may include connecting, attaching, interfacing, orotherwise coupling a treatment or other agent infusion device orreceptacle containing a treatment, an imaging agent, a therapy enhancingor other agent to cannula 392, 692, 1040 to infuse the treatment orother agent to a region of interest of a blood vessel or to tissuesconnected to or adjacent to a blood vessel, such as through hole 394 asshown in FIG. 3. Appropriate treatment agents include one or more drugs,synthetic matter, genes, plant cells, animal cells, human cells, stemcells, bone marrow cells, and the like. According to some embodiments,block 1135 may include connecting an imaging agent or contrast agent tothe cannula. Appropriate imaging agents may include mixtures of contrastand saline and/or other agents as known in the art that allows theballoon to be imaged by an imaging such as fluoroscopy, MRI orultrasound. According to some embodiments, block 1135 may includeconnecting a flush or other therapy enhancing agents into the vessel.Appropriate flush or therapy enhancing agents may include saline orother water based solutions to remove the blood from an energy pathwhere the energy may be sonic, light, electrical or other forms ofenergy.

At block 1140 the inflation-deflation device is transitioned to theinflation latched position to advance the plunger and re-inflate theballoon to the occlusion diameter. Block 1140 may include occluding ablood vessel at a region of interest as described above for block 1125and/or 1120. At block 1140, the latch of the inflation-deflation devicemay be relocked to relocate the plunger at the occlusion location. Block1140 may correspond to transitioning inflation-deflation device 100 fromlatch 150 being in position DEFLAT as shown in FIG. 2 to being inposition INFLAT as shown in FIG. 3, to push a sufficient volume of fluidinto balloon 348 to occlude blood vessel 390 at region of interest 396.Moreover, block 1140 may correspond to pushing the distal housing andthe proximal housing of an inflation-deflation device together, such asusing human hands, to transition a releasable latch from a deflationlatched position, to an inflation latched position. Specifically, block1140 may correspond to pushing a distal and proximal housing of aninflation-deflation device together to cause locks 152 and 154 totransition from recess 486 to recess 482, from recess 586 to recess 582,from recess 786 to recess 782, or from recess 986 to recess 982 asdescribed for FIGS. 4-7 and 9. Similarly, block 1140 may correspond topushing the housings together to cause lock 852 to transition from pinrecess 866 to pin recess 862 as described for FIG. 8. It is contemplatedthat block 1140 includes relocking the latch to the inflation latchedposition as shown in FIG. 3, such as in the case where knob 130 hasalready been rotated to cause plunger 110 to push a sufficient orocclusion volume of fluid to inflate the balloon to occlude the bloodvessel no that when the latch is relocked into the inflation latchedposition, the balloon is reinflated to the occlusion volume/occlusion ODand occludes the blood vessel. Also, block 1140 may correspond to anoperation of the process described above for using system 1000, 1300,1400, and/or device 1360.

Moreover, block 1140 may include holding the inflation volume of fluidin the balloon (e.g., balloon 1048 or 348) for a period of time, such asto occlude blood vessel (e.g., vessel 390) for a selected period of timebefore, during and/or after treatment or injection with a treatment orother agent as described above with respect to FIG. 3 and/or below forblock 1145.

For example, at block 1145 a treatment or other agent is infused to aregion of interest of a blood vessel. Block 1145 may include infusingone or more treatment agents, flushes and/or imaging agents as describedabove with respect to block 1040 and block 1135. Block 1145 may includeinfusing a treatment agent, flush and/or imaging agent to a region ofinterest of a blood vessel, such as through hole 394 as shown in FIG. 3,as otherwise described herein, and/or as known in the art via a catheteror cannula. Such a catheter or cannula may also include the occlusionballoon. Such a catheter or cannula may include other features,components and constructions known to the art. The treatment agent maybe introduced proximal and/or distal to the occlusion.

Thus, blocks 1140 and 1145 may include locking or holding the plunger atlocation L3 to keep balloon 348 occluding vessel 390 as shown in FIG. 3,during treatment, such as for a selected period of time. Appropriatetreatment time periods include those where the blood vessel is occludedfor a reasonable time to avoid damage to the desired target tissue (suchas by occlusion nor treatment for 10, 20, 30, 40, 100, 200, 300, 400 anycombination thereof of seconds, or any number of seconds therebetween).It is contemplated that block 1140 may include treatment of the bloodvessel, surrounding tissue, tissues fed or drained by the vessel andvessels attached to the blood vessel with one or more various treatmentagents, flushes, drugs, synthetic matter, genes, plant cells, animalcells, human cells, stem cells, bone marrow cells, and other solutionsas previously described.

At block 1150 the inflation-deflation device is transitioned to thedeflation latched position to withdraw the plunger and deflate theballoon and remove the occlusion (e.g., caused by the inflated balloon).Block 1150, may correspond to and/or include descriptions above forblock 1130.

Block 1155 is a decision block at which it is decided whether or not tocontinue treatment. If at block 1155 it is determined that treatmentwill not continue, the process continues to block 1160 where treatmentis ended. Alternatively, if at block 1155 it is determined thattreatment will continue, the process returns to block 1140. In somecases continuing treatment corresponds to operations of the processdescribed above for using system 1000, 1300, 1400, and/or device 1360.

Also, according to embodiments, various modifications to the processdescribed above for FIG. 11 may be made. For instance, the position ofblocks 1105 and 1110 may be reversed. Also, in some cases, the positionof block 1135 may be moved to any point in the process prior to block1145. Next, block 1130 may be excluded from the process shown in FIG. 11(e.g., no perfusion until after the region of interest is treated atblock 1145). For example, after the region of interest is occluded atblock 1120, processing may continue to block 1145 (e.g., the latch maybe held locked in the inflation latched position so that treatment agentmay be infused to the region of interest at block 1145). The process maythen continue as shown and described above with respect to FIG. 11.

In other words, block 1130 can be eliminated, but is preferred to allowthe tissue being fed by the vessel to recover (e.g., from lack of oxygenas noted for block 1130) before treatment/infusion from the reducedblood flow that occurred during 1115, 1120 and 1125. Thus, whereocclusion is quickly reached at blocks 1115-1120 (possibly includingblock 1125), blocks 1130 and 1140 can be skipped to reduce the timerequired to perform treatment using an inflation-deflation device (e.g.,according to FIG. 11). This may be benefit certain patients, where ashorter procedure leads to less risk due to anesthesia or otherconsiderations.

In another example, block 1140 may occur during or after 1145. In such acase, all or a portion to the treatment or other agent may be infusedinto the vessel region of interest prior to the occlusion balloon beinginflated to occlude the vessel. Such a modification to the process ofFIG. 11 may have benefits in some treatments where the occlusion isremote from the tissues to be treated. For instance, blood flow maycarry the treatment or other agent to the desired location and then theocclusion causes the flow to stop with the agent at the desiredlocation.

Furthermore, in some embodiments, after block 1155, the cannula andballoon may be moved to a different location in the blood vessel, or inanother vessel within the same person or patient and used to occludeanother region of interest there. Specifically, another vessel positionwithin a blood vessel may be occluded by moving the cannula and balloonafter block 1155 to a different place, position, location, or region ofinterest within the vessel without disconnecting the inflation-deflationdevice or system. Then, the balloon may be re-inflated to occlude thevessel at the new place or location (e.g., continue at block 1115). Insome cases, prior to re-inflating the balloon at block 1125, the knob(and pressure adjustment in some embodiments) of the inflation-deflationdevice may be turned in a direction to retract the plunger towards theproximal end of the inflation-deflation device, back to their initialposition or a position appropriate to the vessel ID at the new location.The process of FIG. 11 may then return to block 1115, where theinflation-deflation device is returned to its inflation latched positionand volume increments may be applied according to a chart, as previouslydescribed, and continue from block 1115 to treat a vessel at a newposition or location. Alternately, the inflation-deflation device(s) orsystem may be disconnected from the catheter/cannula during there-positioning in elastic balloon embodiments or embodiments thatinitially inflate the balloon using a controlled volume of fluid,provided sufficient attention is paid to return the inflation-deflationdevice(s) or systems to their initial conditions and to avoidintroducing air into the components communicating with the occlusionballoon. Compliant balloons may change their nominal or formed OD duringan initial use, such that reconnecting them to a inflation-deflationdevice(s) or systems that initially inflate the balloon to an lowpressure may cause the balloon to inflate to a greater OD than expected.With a greater than expected initial OD, any subsequent incrementalinflation according to a chart in block 1115, as previously described,may provide a balloon OD in excess of a safe OD. Therefore, such adisconnection may not be safe for compliant balloon systems.

The following descriptions provide basic structures and options relatedto the inflation-deflation devices, features, and/or components thereofdescribed herein. For instance, according to some embodiments:

-   1. There may be only one syringe tube and only one plunger. The    syringe tube may be attached either directly or indirectly to the    distal housing. The plunger may be attached either directly or    indirectly to the proximal housing.-   2. There may be cowling-housing features (between the cowling and    the proximal/distal housing that the cowling is not attached to)    and/or retaining pin-housing features that operate such that:    -   a. in the first (inflation) latched position, they hold and        constrain the distal and proximal housings in a position with        enough force to prevent their movement relative to each other in        response to normal handling forces and the force resulting from        the pressure created inside the syringe caused by the balloon        inflation pressure, and such that there is enough volume left in        the syringe to adjust the diameter of the inflated balloon from        its initial diameter to cover the designed range of balloon        outer diameters and, in some specific designs, to inflate the        balloon to its initial diameter.    -   b. in the second (deflation) latched position, they hold and        constrain the distal and proximal housings further apart        relative to the first latched position, such that the plunger        may be moved enough relative to the syringe tube to deflate the        balloon, but not enough to disengage the plunger from the        syringe tube and with enough force that it will remain in the        second latched position (the balloon will remain deflated) when        subjected to normal handling forces. This second latched        position doesn't have the critical “no movement allowed”        constraint that the first latched position has.    -   c. rotation may be prevented between any two or three of the        distal housing, the proximal housing and the cowling, as        required or desired for the particular chosen configuration of        the inflation-deflation device. Constraining rotation makes it        less critical which part of the device the user is holding on to        with one hand when he rotates a knob or cowling with the other.        -   The features include a releasable lock(s) or latch(es) and a            mechanical interference(s). The retaining pin(s), if any,            may be constrained between any two of the distal housing,            the proximal housing or the cowling. At least one of the            constraints may allow the desired longitudinal motion            between the connected portions during transitioning between            the second position and the first position.        -   The cowling may have the safety function of covering any            pinch points to prevent pinching during a transition from            the second latched position to the first latched position.-   3. There may be three ways to move the plunger relative to syringe    body in a relatively continuous manner:    -   a. A screw mechanism coupling between the cowling and the        housing that it is attached to. The cowling may be rotated        relative to the housing that it is attached to.    -   b. A screw mechanism coupling between the syringe tube and the        distal housing. A knob rotation may operate the screw mechanism.    -   c. A screw mechanism coupling between the plunger and the        proximal housing. A knob rotation may operate the screw        mechanism.    -   Any of these three ways may be provided with a counter or other        rotation indicator. Any of these three ways may be provided with        a releasable lock mechanism to prevent accidental adjustment.        The releasable lock configuration may be designed to provide an        incremental latching mechanism such that equal increments of        fluid may be forced out into the balloon.    -   It may be preferred that any one of these three ways may provide        one of two functions:    -   a. Conveniently inflate the balloon(s) to its initial outer        diameter. This could be to a specific controlled volume(s) of        fluid as shown on an indicator or counter or, if a pressure        gauge is included, then the inflation could be to a specific        controlled pressure(s) as well as a controlled volume. Of        course, any two ways could also be utilized to create a device        that has one control for a controlled pressure initial        inflation(s) and another control for a controlled volume initial        inflation(s)    -   b. Increment the outer diameter of the balloon(s) using        incrementally equal controlled volumes of fluid. The current        inflation increment may be shown on an indicator or counter.    -   In some cases, only one way alone may do both, but for the ease        of use problems discussed herein, separate functions may be        preferred. If only function “b” is incorporated, then the device        is a non-integrated controlled volume inflation-deflation        device. If both functions “a” and “b” are incorporated, then the        device is an integrated controlled volume inflation-deflation        device.-   4. The function of conveniently inflating the balloon to its initial    outer diameter using a specific controlled volume of fluid may also    be provided by the mechanism described in 1 and 2 above; where a    mid-latched position is provided. Transitioning the device from the    mid-latched position to the first (inflation) latched position    pushes a controlled volume of fluid into the cannula/balloon. There    may be several mid-latched positions provided. Two options of    providing multiple mid-latched positions for inflating balloons with    different initial inflation volumes or to different initial outer    diameters are described herein. A mid-latched position may be    positive, that is it should not be loose or wobbly or there will be    uncertainty in the amount of fluid to be injected into the    cannula/balloon and thus, additional uncertainty in the initial    outer diameter of the balloon (a safety issue). For instance, the    ball may engage the OD of the recess hole or both sides of the    groove.-   5. Any inflation-deflation device may be provided with the described    low compliance extension tube/tube-connector assembly attached to    its syringe tube (e.g., see line 1050 of FIG. 10).

Although the paragraphs above are numbered and lettered, the numberingand lettering does not, necessarily, indicate an order of preference. Asnoted, embodiments can include a knob coupled to the screw mechanismhaving at least one indexing lock to engage at least one recess in asurface of the proximal housing adjacent the knob, such that rotatingthe knob causes the at least one indexing lock to engage the at leastone recess and to move the plunger to a plurality of locations along thelength. In such cases, it is considered that to operate the knob in anincremental manner, all that may be required is one (1) indexing lockand one (1) recess. In this instance, it takes one revolution of theknob to inject/withdraw one incremental volume of fluid into/from theballoon (move the plunger an incremental length within the syringetube). More than one volume increment per knob rotation may bepreferred, as this reduces the amount of knob turning the user isrequired to do during a procedure and it is difficult or impossible fora user to turn a knob 360 degrees to the next releasably latchedposition without releasing the knob and turning it some more. Thushaving more than volume increment per knob rotation improves device easeof use. It will also work in the instance that there are one or moreindexing lock(s) in combination with one or more recess(es). Forinstance, in the case of one indexing lock and three (3) recesses, therewould be three (3) incremental inflation volumes per rotation of theknob. In another instance, in the case of four (4) indexing locks andone (1) recess, there would be four (4) incremental volumes per rotationof the knob. In the previous instances, one could also design thelocation(s) of the indexing lock(s) and/or recess(es) such that theincremental volumes are equal. Equal incremental volumes may bepreferred, because they can be the simplest design, the safest (limitvessel over-stretch), and/or the easiest to use (limit amount of knobturning). In another instance, in the case of two (2) indexing locks andthree (3) recesses, all equally spaced around the knob shaft, therewould be six (6) equal volume increments per knob rotation. In any ofthese instances the forces applied by the indexing lock(s) to the knobmay not be balanced, and thus a bending moment will be applied to theknob shaft that can interfere with the smooth turning of the knob, thecounter mechanism, or the screw mechanism (which moves the plunger).However, one could design around these problems and make a device thatoperated acceptably.

Preferred embodiments include two (2) or more similar indexing locks andtwo (2) or more similar recesses, arranged such that all the indexinglocks engage and disengage a recess simultaneously (or nearlysimultaneously) during knob rotation and the indexing locks and recessesare arranged at equal distances from the knob shaft center and at equalangular intervals around the shaft. Thus, there may always be at leasttwo (2) increments per knob rotation, the angular rotation of eachincrement is equal (each volume increment or length of plunger motionper increment is equal), either the ratio of indexing locks to recessesor the ratio of recesses to indexing locks is a whole number (1, 2, 3 .. . ) and the forces applied to the knob are balanced in a manner thatminimizes any resultant bending moment applied to the knob shaft. Theseembodiments include the simplest designs and constructions that providemultiple (or a desired number of) volume increments per knob rotation,equal volume increments and minimize the bending moment applied to theknob shaft. For instance, in a preferred embodiment that comprises two(2) indexing locks and four (4) recesses; there would be four (4) equalincremental volumes per rotation of the knob. Referring to FIGS. 1C and1D, a preferred embodiment comprised of three (3) indexing locks andthree (3) recesses is shown and thus there are three (3) equalincremental volumes per rotation of the knob. Of course, more complexdesigns of multiple index locks and recesses can be designed thatprovide these attributes. It is also considered that the positions ofthe recess(es) and the indexing lock(s) may be exchanged

Balloon 348, balloon 648, balloon 1048, balloon 1448, a balloon foroccluding and perfusing a blood vessel as described in FIGS. 3, 6, 10,12, and 14 may have properties, functionality, operate, and/or have anouter diameter that expands in response to incremental equal volumes ofinflation fluid. For example, those balloons may function similarly toballoon 1548 as described below with respect to FIGS. 15-18.

FIG. 15 is a cross-sectional side view of an occlusion balloon attachedto a catheter inflated by a minimal volume of fluid (deflated). FIG. 15shows apparatus 1500 including cannula 1540 having a dimension suitablefor percutaneous advancement through a blood vessel, such as to a regionof interest to treat the region of interest with a treatment agentinfused from cannula 1540 or another cannula. Cannula 1540 has diameterDC, longitudinal axis LAXC, proximal end 1506 and distal end 1504.Balloon 1548 is axially attached to the exterior surface of cannula 1540at or adjacent distal end 1504.

Moreover, balloon 1548 may be described as having a cross-sectionalprofile or a contour that includes tapered (conical) ends extendingproximally and distally to a cannula to which they are attached andincludes a center portion between the tapered ends that defines acylindrical shape. In some cases, balloon 1548 may be, an occlusiondevice or balloon that has a nominal or formed diameter that requires aninitial volume of fluid to be injected into the balloon to inflate itsuch that the folds of the balloon are removed and/or it assumes aninitial shape or OD, and has an outer diameter that increases byrelatively (compared to other balloon shapes) equal increments indiameter increase in response to being inflated by equal increments involume over a range of diameters. For example, balloon 1548 may have across-sectional profile or a contour that includes tapered (conical)ends extending proximally and distally to a cannula to which they areattached and includes a center portion between the tapered ends thatdefines a cylindrical shape. In some cases, as opposed to balloon 1548,other more curved balloon shapes (i.e. elliptical, spherical) may have amore rapid decrease in their diameter increase increment per inflationvolume increment as their diameter increases. For balloon 1548, havingrelatively equal or more equal increments in diameter increase inresponse to being inflated by equal increments in volume over a range ofdiameters is desirable because this also minimizes the number ofrequired inflation increments. Also, in some cases balloon 1548 may havea nominal or formed OD, such as an OD greater than the OD of thecatheter shaft the balloon is attached or mounted on, when deflated, andthat the balloon must be folded around the catheter shaft to produce theminimum catheter profile to facilitate catheter insertion/positioning inthe vasculature (e.g., into a blood vessel).

FIG. 15 also shows balloon 1548 having inflation volume V1 and totallength LB. In addition, balloon 1548 includes tapered ends T1 and centerportion CPI. Center portion CP1 extends for length LCP of total lengthLB. Balloon 1548 has outer diameter DM1, which may be defined as thediameter at a location of balloon 1548 where tapered ends T1 meet centerportion CP1. Balloon 1548 has diameter D1, such as a maximum diameteralong center portion CP1 when inflated with volume V1. Balloon 1548 maybe inflated and deflated, such as by being in communication with a lumenor tube (e.g., communication by the lumen or tube having an opening inthe inner chamber or inside of balloon 1548) extending through cannula1540 and to an inflation device such as a device for inflating balloon1548 with gas (e.g., air) and/or liquid (e.g., fluid such as salinesolution, contrast solution, water, and the like). Balloon 1548 may beinflated and deflated, by an inflation-deflation device such asinflation-deflation device 100, 200 or an inflation-deflation deviceincluding structure 400, 500, 700, 800, 900, 1010, 1310, 1410; and/oraccording to a process described above for FIG. 11 as described herein.

In some embodiments, cannula 1540 may have an outer diameter DC ofbetween 1 and 7 mm, such as by having an outer diameter of 1 mm, 2 mm,2.5 mm, 3 mm, 3.5 mm, 4 mm, 4.5 mm, 5 mm, 6 mm, or 7 mm. Moreover,cannula 1540 may be guidewire compatible such as compatible to be guidedby a guidewire having an outer diameter of approximately 0.014 inches,0.018 inches, 0.025 inches or other guidewire OD appropriate for thecannula OD, in a “over-the-wire” configuration where the catheter isguided over the guidewire, such as by having the guidewire disposedwithin a lumen of cannula 1540 and pushing cannula 1540 along theguidewire to the region of interest. Alternatively, cannula 1540 may beguided by a guidewire using a “rapid exchange” configuration, such aswhere an access hole is cut through the surface of the cannula to alumen within so that a guidewire can be fed through the hole and lumenand out the distal end of the cannula.

Moreover, cannula 1540 may be a catheter having a number of tubes,internal tubes, or lumens disposed within cannula 1540, such as byhaving tubes within cannula 1540 to inflate balloon 1548, to infuse atreatment agent to a region of interest of a blood vessel eitherproximal or distal to balloon 1548, and to accommodate a guidewiredisposed therein for guiding as described above. In addition, cannula1540 may be configured to mount or accommodate sensors or devices suchas electrodes, electrical wires, pressure transducers, optical fibers,imaging cores, and the like, as is known in the art. In addition, aproximal end of cannula 1540 that is kept external to a patient duringuse may include a triple arm or extension tubes that allow Luer accessto a balloon inflation lumen, a guidewire lumen, and an infusion lumenwithin the cannula.

In some embodiments, balloon 1548 and cannula 1540 may be used toocclude various regions of interest of one or more blood vessels, suchas without withdrawing the cannula and balloon from the vasculature of aperson as described for the process of FIG. 11. For instance, theposition of cannula 1540 and balloon 1548 may be adjusted to place theballoon in various positions within one or more blood vessels of aperson with or without disconnecting an inflation-deflation device frombeing coupled to cannula 1540, to inflate and deflate balloon 1548 toocclude and perfuse blood flow in a blood vessel at a region of interestas described for the process of FIG. 11.

Balloon 1548 may be designed to have certain “properties” prior toinflation, during inflation, while occluding a blood vessel, wheninflated with a volume sufficient to occlude a blood vessel, duringdeflation, when inflated with a volume during perfusion of a bloodvessel, or when inflated and deflated otherwise. Specifically, thedesign may consider or select specific materials, inflation volumes,lengths, diameters, material thickness, tapered ends, center portions,and the like, so that balloon 1548 will have one or more specific“properties,” as described herein. For example, as shown in FIG. 15,balloon 1548 may represent a balloon that is uninflated, folded or thatis inflated with volume V1 which may represent a minimal or zeropressure or volume (e.g., minimal volume V1) of fluid as describedherein. In some cases, as shown in FIG. 15, balloon 1548 may be aballoon designed to occlude a blood vessel, such as an artery or vein,including those of the human heart. Specifically, as shown in FIG. 15,balloon 1548 may be ready for insertion with cannula 1540 andpercutaneous advancement to a region of interest of a blood vessel whereballoon 1548 will be inflated and deflated, at least once, to occludeand/or perfuse blood at the region of interest.

In addition, balloon 1548 may have the properties and/or functionalitydescribed above with respect to balloon 348, balloon 648, 1048 and/orballoon 1448 for occluding and perfusing a blood vessel, such asdescribed above with respect to the processes of FIG. 11.

In coronary artery applications, balloon 1548 may have total length LBbetween 1 and 10 mm, such as by having length LB of 2 mm, 3 mm, 4 mm, 5mm, 6 mm, 7 mm, 8 mm, or 9 mm. Consequently, balloon 1548 may havecenter portion length LCP of between 0.5 mm and 8 mm, such as by havinglength LCP of 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, or 7 mm.Correspondingly, tapered ends T1 may be equal or unequal in length andmay be defined by (a) a portion of the balloon thicker in material thancenter portion CP1, (b) a portion of the balloon having an outerdiameter contour or shape distinctive from center portion CP1, and/or(c) a portion of the balloon defining a certain lower range of outerdiameter than center portion CP1. Naturally, in other vesselapplications, these sizes of the balloon may be increased or decreasedto accommodate the vessel size range to be occluded.

In some cases, the distinction between center portion CP1 and taperedends T1 may be defined by a geometric distinction or shape, such as adistinct curve in profile or cross-section where center portion CP1meets tapered end T1. Tapered (conical) ends form a near linearlyincreasing outer diameter geometry between where the balloon attaches tocannula 1540 near distal end 1506 and proximal end 1504 and centerportion CP1. Also, center portion CP1 may define a cylindrical outerdiameter profile (e.g., looking down axis LAXC) that is approximatelyequal in outer diameter along center portion CP1 (e.g., along length ofcenter portion LCP, such as shown in FIG. 15).

The thickness of the material of balloon 1548 may decrease along ends T1with distance towards portion CP1 from where ends T1 join the surface ofcannula 1540. Thus, the material may be thicker at location 1552 than atlocation 1554. Similarly, the thickness may decrease along portion CP1with distance from ends T1 towards the center of portion CP1. Here, thematerial may be thicker at locations 1552 and 1554 than it is atlocation 1556. For example, the material of balloon 1548 may be thickestnear location 1552, thinner at location 1554, and thinnest at location1556.

Thus, for balloon 1548, it is possible to select a balloon material ormaterials; tapered ends T1 shape, length, material, and thickness ofmaterial; and center portion CP1 length, material, and thickness ofmaterial to define a “property” such that when inflated, balloon 1548will expand in its maximum outer diameter size to equally increasing ornearly equally increasing outer diameters in response to being inflatedwith equal inflation volume increments, such as incrementally equalvolumes of inflation fluid. Nearly equally increasing outer diametersmay be increases in outer diameter by sized increments within 5 or 10percent of each other in response to incrementally equal volumes ofinflation fluid over a selected range of volumes. Also, equallyincreasing outer diameters may be described as relatively equallyincreasing outer diameters (e.g., increasing by a constant additionaldiameter with respect to each prior diameter) when inflated with aplurality of equally increasing inflation volumes. For some balloonshapes and constructions, the incremental increase in balloon OD inresponse to an incremental inflation volume decreases at a rapid ratewith each additional incremental inflation volume. In occlusion balloonsystems, especially those that conveniently occlude vessels over a widerange of ID's, this is undesirable because it increases the number ofinflation volume increments required to cover the desired balloon ODrange (vessel ID occlusion range) and still have the largest OD changebe a safe increment (not over-stretch the vessel, as previouslydescribed).

For instance, tapered ends T1 may maintain a relatively linear and smallincrease in their length and during and over the range of inflation ofthe balloon. Center portion CPI may define a relatively flat or constantouter diameter at lower inflation volumes of the balloon, but begins toincreasingly bow so that the center of center portion CP1 increases indiameter greater than the rest of center portion CP1 at higher inflationvolumes. Thus, while at low volumes or a low OD, a fixed additionalinflation volume will increase the outer diameter by a specific amountbecause that fixed volume may increase the diameter across the entirecenter portion, length LCP. Alternatively, while at higher inflationvolumes or larger OD, the same fixed additional inflation volume willincrease the outer diameter by an almost equal specific amount since itmust only fill the lower volume needed to increase the outer diameternear the center of the center portion and not the much greater volumethat would be required to inflate the entire length to the increaseddiameter.

In one example, balloon 1548 may increase by outer diameter incrementson the order of 0.25 mm or less for each increment of inflation volumeof between 0.02 and 0.005 cubic centimeters (cc), or less. For example,balloon 1548 could increase by increments of 0.03 mm, 0.025 mm, 0.0225mm, 0.02 mm, 0.0175 mm, 0.015 mm, or less in response to incrementalincreases in inflation volume of 0.02 cc, 0.0175 cc, 0.015 cc, 0.0125cc, 0.01 cc, 0.0075 cc, 0.05 cc, 0.025 cc, or less.

In some cases, the balloon diameter increased with oneinflation-deflation device incremental increase in equal volumes ofinflation fluid by between 0.12 mm and 0.19 mm. In such an example, asafe over-stretch of the vessel (maximum safe vessel stretch beyond thestretch required to attain an occlusion) could be considered to be, atleast, 0.19 mm. For example, an inflation-deflation device as describedabove or using a process as described above, may be used to inflateballoon 1548 with incremental equal increases in inflation volume toincrease the outer diameter of balloon 1548 by equal incrementalincreases of one of 0.12, 0.13, 0.14, 0.15, 0.16, 0.17, 0.18, and 0.19mm increments in response to each incremental equal increase ininflation volume. It is also contemplated that balloon 1548 may respondto the incremental equal increases in inflation volume by expanding toeach increment with a decrease in outer diameter change between 0.19 mmand 0.12 mm in the range described above where each incremental increasein the outer diameter is not equal to every other incremental increasein the outer diameter. Thus, although incremental equal volumes oninflation fluid are being introduced into balloon 1548, the outerdiameter may increase by one amount (e.g., such as 0.013 mm) in responseto one incremental increase inflation volume, but increase in outerdiameter by another amount (e.g., such as 0.012 mm) in response to thesubsequent incremental equal volume of inflation fluid. However, therate of this decrease (or increase) may be reduced by the design of theballoon as previously described.

Also, according to some embodiments, the cannula inside or along sidethe balloon may have a smaller OD than a proximal portion of the cannulaand therefore, the OD of the catheter doesn't necessarily have tosubstantially increase the OD of the catheter in the region where theballoon is mounted. For instance, the lumen/tube portion that inflatesthe balloon can be terminated at the proximal end of the balloon and theOD/ID of a distal (to the balloon's proximal end) infusion and/orguidewire lumen/tubing can be reduced to make the cannula OD smalleralong the length of the balloon. For example, although FIG. 15 showsdiameter DM1 and diameter D1 greater than diameter DC, it iscontemplated that balloon 1548 may be attached over a portion of cannula1540 having an inner structure or tubing such that the exterior surfaceof cannula 1540 has a smaller OD under balloon 1548. In some cases,structure of or within cannula 1540 may exist under balloon 1548 suchthat the outer surface of cannula 1540 has a smaller OD for at least aportion of length LB. Thus, diameter DM1 and/or diameter D1 may be equalto or even slightly less than diameter DC prior to inflation, such aswhen balloon 1548 is at a zero or minimal inflation volume (e.g.,deflated and/or folded).

The increases in diameter, volume, and/or pressure described above mayoccur over a range of volumes starting at V1, V2, or V3 and continuingover a range of volumes, such as to V4, as described below in FIGS.16-18.

For example, FIG. 16 is a schematic cross-sectional side view of theballoon of FIG. 15 inflated with a greater volume of fluid, such asinflated to a low pressure and/or to a volume which corresponds to itsformed or nominal OD. In FIG. 16, balloon 1548 is shown having centerportion CP2 and tapered ends T2. For example, tapered ends T2 may definelinear increases in outer diameter similar to those described above withrespect to tapered ends T1 (e.g., extending away from the cannulasurface over length LB at a greater rate than T1). Similarly, centerportion CP2 may define a cylindrical outer diameter having asubstantially equal outer diameter along the length of center portionCP2 as described above with respect to CP1. FIG. 16 shows balloon 1548inflated to outer diameter D2 at center portion CP2, and diameter DM2 atthe meeting of tapered ends T2 and center portion CP2. Thus, as shown inFIG. 16, center portion CP2 may define an approximately cylindricalshape extending along longitudinal axis LAXC between tapered ends T2. Asnoted above for tapered ends T1, tapered ends T2 may have a thickerthickness of balloon material than center portion CP2. Also, thematerial may be thicker near the point at which balloon 1548 attaches tocannula 1540 than portion CP2, and thicker at the point at which thetapered ends meet center portion CP2 (e.g., such as at diameter DM) thanat the center of center portion CP2.

Diameter D2, may be reached, such as in response to being inflated withvolume V2 (such as volume V1 plus an initial inflation volume of aliquid or as an initial inflation to an initial pressure as describedherein) where volume V2 is greater than volume V1. It is contemplatedthat the difference between volume V2 and volume V1 may be apredetermined increase in inflation volume, such as a volume of between0.04 and 0.25 cc for coronary artery applications. For example, as shownin FIG. 16, balloon 1548 may represent a balloon that is inflated withvolume V2, which may represent a nominal pressure or volume (e.g.,nominal volume V2) of fluid as described herein.

Balloon 1548 may have a property to accommodate and at least 1.5 mmincrease in diameter from its nominal or, formed diameter, such asdiameter D2 as shown in FIG. 16. Thus, an embodiment of balloon 1548(for instance a coronary artery embodiment) attached to cannula 1540,where cannula 1540 is a catheter having an outer diameter DC between 0.8to 1.8 mm, and a nominal balloon diameter D2 for balloon 1548 may be 3.0mm. In another instance (for instance a coronary artery embodiment),where cannula 1540 has the same outer diameter, balloon 1548 may have anominal outer diameter D2 of 4.0 mm. For example, these embodiments maybe for a coronary artery application and may use one of two 2 Pebax®balloons as a compliant occlusion balloon for a procedure. One balloonhas a nominal/formed OD of 3.0 mm and the other has a nominal/formed ODof 4.0 mm. Both balloons are designed to be inflated 1.5 mm beyond theirnominal OD without bursting. This gives one balloon a nominal range inOD of 3.0-4.5 mm and the other 4.0 mm to 5.5 mm. Both balloons aredesign to be mounted on the same cannula OD (e.g., outer diameter DC ofcannula 1540). In some cases, that cannula OD is about 1.2 mm.Experimentation has found that a coronary artery requires about 0.5 mmoverstretch (increase in ID over its apparent/measured ID byfluoroscopy) to create an effective occlusion. Thus, one balloon isdesigned to occlude coronary arteries with ID's of 2.5 to 4.0 mm and theother 3.5 to 5.0 mm. The overlap of the ranges by 0.5 mm is to allow forvessel ID measurement uncertainties, such that choosing the ballooncovering the measured vessel ID most within its range will safelyocclude a vessel in the 3.5 to 4.0 mm ID range that is incorrectlymeasured with an error of 0.5 mm. In actual fact, it is possible toinitially inflate the balloons to a low pressure (0.5 ATM), so thatneither balloon will damage (overstretch an unnecessary amount) anartery due to its initial inflation. For instance, the balloon may keepa fold in it as it is inflated (e.g., using the process of FIG. 11).Sometimes, the larger balloon may be chosen and may obtain a good safeocclusion either with the initial inflation or with very few subsequentincremental volume inflations. During a procedure, this may lead to timesaving, which can be very important to reduce the length of theprocedure. If the system uses a controlled volume for the initialinflation, then purposely choosing the over-sized balloon could resultin vessel damage because the balloon would attain its nominal OD uponits initial inflation and thus force the vessel ID to that size. Becauseof this, a system/device that initially inflates the balloon to acontrolled low pressure may be more forgiving and safe

In one specific example, balloon 1548 may have a nominal diameter of D2of 3.0 mm that may expand to have an inflated outer diameter of up to3.75 mm before being permanently deformed. An alternative way ofthinking of this is that balloon 1548 beginning with a nominal balloondiameter D2 of 3.0 mm may have an elastic recoil of about 0.75 mm andthus, if inflated up to 3.75 mm and deflated, it would return to itsinitial 3.00 mm diameter, however if inflated to 4.2 mm, it would onlyreturn to 3.45 mm. Similarly, for balloon 1548 having nominal diameterD2 of 4.0 mm, the balloon may have an elastic recoil of 1.0 mm such thatwhen inflated to greater than 5.0 mm, the balloon will not return to itsoriginal 4.0 mm when deflated. Moreover, once the outer diameter ofballoon 1548 is taken beyond a certain diameter, the “elastic limitdiameter,” the diameter of balloon 1548, may not return to the initial,minimal or nominal diameter D2 without folds in the balloon material.The behavior of compliant occlusion balloons can often be characterizedin this manner.

Furthermore, in some embodiments, the initial controlled inflationpressure for balloon 1548 to inflate it to its nominal or formed OD mayoccur at between 0.2 atmospheres (ATM) and 2.0 ATM in pressure. Forexample, balloon 1548 may attain its nominal inflation volume VOL2 andOD D2 when inflated with 0.4 ATM, 0.5 ATM, 0.6 ATM, or 1.0 ATM inpressure by a device or system that performs the initial ballooninflation using a controlled low pressure. In some embodiments, wherethe device or system performs the initial balloon inflation using acontrolled low pressure, the device may be manipulated to initiallyapply a larger pressure and then stabilize the pressure at a lowervalue. For instance, if the plunger relative to the syringe body isadvanced at a rate that applies 1 ATM at the proximal end of thecannula/catheter during the initial filling of the balloon, the pressurein the balloon will be very low and there will be no danger of applyingdamaging pressures or balloon OD's to the vessel. Once the pressure inthe balloon begins to rise, the rate of plunger advance relative to thesyringe body required to keep the applied pressure a 1 ATM will benoticeably reduced. At that time, the rate of plunger advance relativeto the syringe body can be even further reduced and adjusted tostabilize the applied pressure at 0.5 ATM. Thus, the pressure seen bythe balloon may be limited to only 0.5 ATM with this technique. Theadvantage of this technique is that the time required to initiallyinflate the balloon to the desired controlled low pressure, in thisexample 0.5 ATM, is substantially reduced by the increased fluidflowrate produced by the higher pressure portion of the inflationprocedure, in this example 1 ATM.

The increases in diameter, volume, and/or pressure described above mayoccur over a range of volumes starting at V1, V2, or V3 and continuingover ranges of volume, such as to V4, as described below in FIGS. 17-18.

FIG. 17 is a schematic cross-sectional side view of the balloon of FIG.16 inflated with a greater volume of fluid. FIG. 17 shows balloon 1548having outer diameter D3 when inflated with inflation volume V3. In FIG.17, balloon 1548 is shown having outer diameter D3 and diameter DM3where tapered ends T3 meet center portion CP3. Diameter DM3 is less thandiameter D3.

The increase in volume from volume V2 to volume V3 may be one or moreincremental equal increases in inflation volume as described herein.Thus, diameter D3 may be reached after one or more incremental equal ornearly equal increases in outer diameter of the balloon in response tothe incremental equal increases in inflation volume.

Specifically, tapered ends T3 may define linear or curved increases inouter diameter greater than that of ends T2 with distance along lengthLB away from where balloon 1548 joins the surface cannula 1540. Also,center portion CP3 may define a more spherical or curved shape betweentapered ends T3 with respect to across section along axis LAXC (e.g., asshown in FIG. 17) so that outer diameter D3 is greater than diameter DM.Specifically, center portion CP3 may bow into the curved shape becausethe thickness of the balloon material along portion CP3 is less than thethickness of the balloon material at tapered ends T3 and the lowestenergy state of an inflating body is to inflate in an increasinglyspherical manner. As a result of this curvature, the balloon volumechanges as the balloon's occlusive OD (D2, D3, D4) is increased, becomesmuch more linear than that of other common occlusive balloon shapes,such as spherical balloons. Thus, this design (going from a straightcylinder with tapers shape to a more spherical shape in the balloon'sdesigned OD range) a can be adapted to a controlled volumeinflation-deflation device an efficient and safe manner. Balloon ODincrements can be thus controlled in a narrower range (OD increment sizeis the Max. over-stretch of the vessel that may occur using a safeocclusion procedure, such as the method of FIG. 11). The closer balloonOD increments are to each other over the balloon OD range, the fewerinjection volume increments are required.

Thus, balloon 1548 can be safely and conveniently inflated withincremental equal increases in inflation volume to occlude a bloodvessel over a defined range of balloon OD's. For example, FIG. 18 is across-sectional side view of the balloon of FIG. 17 inflated with agreater volume of fluid and occluding a blood vessel at a region ofinterest. FIG. 18 shows balloon 1548 occluding blood vessel 1590 atregion of interest 1596 and inflated with inflation volume V4. In FIG.18, balloon 1548 is shown having outer diameter D4, such as a maximumouter diameter along center portion CP4 when the balloon is inflatedwith volume V4 or an outer diameter while the balloon occludes bloodvessel 1590. The increase in volume from V3 to V4 may be one or moreincremental equal increases in inflation volume as described herein(e.g., such as an increase as described above with respect to thedifference between volume V2 and volume V3).

Balloon 1548 is shown having tapered ends T4, center portion CP4, anddiameter DM4. As shown in FIG. 18, balloon 1548 defines diameter DM4where tapered ends T4 meet center portion CP4. Diameter DM4 is less thandiameter D4. Tapered ends T4 may define linear or curved increases inouter diameter greater than that of ends T3 with distance along lengthLB away from where balloon 1548 joins the surface of cannula 1540.Center portion CP4 may define spherical or curved shape with respect toaxis LAXC similar to that described above with respect to center portionCP3, except center portion CP4 extends greater in outer diameter fromdiameter DM4, than diameter D3 extends from diameter DM3.

In some embodiments, diameter D4 is a diameter between 2 and 10 mm indiameter, such as a diameter of 2 mm, 3 mm, 3.5 mm, 4 mm, 4.5 mm, 5 mm,5.5 mm, 6 mm, 7 mm, 8 mm, 9 mm, or 10 mm. Moreover, volume V4 may definea total volume, occlusion volume, or inflated volume for balloon 1548.Volume V4 may be a volume in the range of between 0.05 cc and 1.5 cc,such as a volume of 0.05, 0.1, 0.15, 0.2, 0.3, 0.4 0.5 cc, 0.6 cc, 0.7cc, 0.8 cc, 0.9 cc, 1 cc, 1.1 cc, 1.2 cc, 1.3 cc, 1.4 cc, or 1.5 cc. Forexample, when V4 is approximately 0.12 cc of fluid, balloon 1548 mayhave outer diameter D4 of between 3.5 and 4.5 mm. Also, the differencebetween volume V4 and volume V2 may include one or more incrementalequal volumes of inflation fluid, such as between 1 and 20 increments offluid pushed into balloon 1548 by an inflation-deflation device (e.g.,inflation-deflation device and/or structures described above withrespect to FIGS. 1-10 and 12-14) and/or using processes described abovewith respect to FIG. 11 (e.g., such as described at blocks 1115, 1120and 1125).

It is contemplated that balloon 1548 may be deflated to perfuse blood ata region of interest of a blood vessel. For example, after inflation toocclude the blood vessel as shown in FIG. 18, the volume of inflationfluid within balloon 1548 may be reduced to allow perfusion of bloodwithin vessel 1590. Such deflation may include deflation as is describedabove with respect to balloon 348 and FIG. 3; and/or blocks 1130 or 1150of FIG. 11. Moreover, after deflation, balloon 1548 may be reinflated toocclude a blood vessel, such as described above with respect to balloon348 and FIG. 3; and/or block 1140 of FIG. 11. Thus, balloon 1548 may beinflated to occlude a blood vessel, deflated to allow perfusion,reinflated to occlude the blood vessel and left inflated while atreatment agent is infused into the blood vessel, and then deflated toallow perfusion. That process of inflation to occlude, infusion of atreatment agent to treat, and deflation to perfuse a blood vessel may berepeated as desired.

Specifically, design selection or “properties” of balloon 1548 may allowthe balloon to revisit the shapes, contours, outer diameters, andvolumes when being subsequently deflated, re-inflated, and/orre-deflated to occlude and/or perfuse blood flow in one or more regionsof interest of one or more blood vessels. For example, balloon 1548 mayor may not revisit the same outer diameter (e.g., diameter D2, D3,and/or D4) when inflated with the same volumes (e.g., volumes VOL2,VOL3, and/or VOL4) a second time, after being deflated. It may beappreciated that after initial inflation to occlude a blood vessel, whenbeing deflated, or when being inflated and deflated for such a purpose,if balloon 1548 is a compliant balloon design (the balloon material isstretched beyond its elastic range at an inflated OD) may vary in shape,contour, outer diameter, and volume, especially if a smaller occlusiveOD is attempted to be set in a smaller vessel after a larger occlusiveOD has been attained in a larger vessel. Thus, in some balloon 1548smaller vessels first to avoid the impact of balloon shape/OD changes ata low controlled initial inflation pressure in the event such a deviceor system is disconnected and then reconnected to the cannula/catheterof the balloon.

An important point about FIGS. 15-18 is that the tapered occlusionballoon design tends to even out the incremental OD increase of theballoon for equal increments of volume injected by a controlled volumeinflation-deflation device into the balloon as the cylindrical portionof the balloon goes from a straight cylinder shape to a more sphericalshape over a range of OD's. Thus, this design (going from a straightcylinder shape to a more spherical shape in the balloon's OD range) acan be adapted to a controlled volume inflation-deflation device in anefficient and safe manner. Balloon OD increments can be thus controlledin a narrower range (OD increment size is the Max. over-stretch of thevessel that may occur using a safe occlusion procedure). The closerballoon OD increments are to each other over the balloon OD range, thefewer volume injection increments are required. In this regard, thetapered occlusion balloon design may be much better than other commonocclusion balloon designs, like spherical balloons. Another importantpoint about tapered balloons is that they may lend themselves well tohaving balloons of different OD ranges be operated by the same inflationvolume increment (same controlled volume inflation-deflation device) andstill have very nearly equal (or substantially equal) balloon ODincrements.

As mentioned above for FIGS. 15-18 a tapered occlusion balloon designmay lend to having balloons of different OD ranges be operated by thesame inflation volume increment (same controlled volumeinflation-deflation device) and still have very nearly equal balloon ODincrements. For example, this may allow use of the same controlledinflation-deflation device to operate 2 different balloon designs, onewith a formed/nominal OD of 3.0 mmm and one with a formed/nominal OD of4.0 mm and thus, safely, efficiently and conveniently occlude a widerrange of vessel ID's. For example, FIGS. 19-22 are a cross-sectionalside view of an occlusion balloon attached to a catheter inflated by avolume of fluid. Specifically, FIG. 19 is a cross-sectional side view ofan occlusion balloon attached to a catheter inflated by a minimal volumeof fluid (deflated). FIG. 20 is a schematic cross-sectional side view ofthe balloon of FIG. 19 inflated with a greater volume of fluid; FIG. 21is a schematic cross-sectional side view of the balloon of FIG. 20inflated with a greater volume of fluid; and FIG. 22 is across-sectional side view of the balloon of FIG. 21 inflated with agreater volume of fluid and occluding a blood vessel at a region ofinterest.

FIG. 19 shows apparatus 1900 including cannula 1940 having a dimensionsuitable for percutaneous advancement through a blood vessel, such as toa region of interest to treat the region of interest with a treatmentagent infused from cannula 1940 or another cannula. Cannula 1940 hasdiameter DC, longitudinal axis LAXC, proximal end 1906 and distal end1904. Balloon 1948 is axially attached to the exterior surface ofcannula 1940 at or adjacent distal end 1904. FIG. 19 also shows balloon1948 having inflation volume V5 and total length LBSF. In addition,balloon 1948 includes tapered ends T5 and center portion CP5. Centerportion CP5 extends for length LCPSF of total length LBSF. Balloon 1948has outer diameter DM5, which may be defined as the diameter at alocation of balloon 1948 where tapered ends T5 meet center portion CP5.Balloon 1948 has diameter D5, such as a maximum diameter along centerportion CP5 when inflated with volume V5.

Apparatus 1900, parts, features, functions, dimensions, design, and/ormanufacture thereof may be similar to those corresponding for apparatus1500, except that length LCPSF is shorter than length LCP (and thus,length LBSF is shorter than length LB). Also, D6 (the formed, beginningor nominal OD) is larger than D2, D7 is larger than D3, and D8 is largerthan D4. In some cases, D1 can equal D5. Moreover, volume V5, V6, V7,and V8 may or may not equal V1, V2, V3, and/or V4 respectively.Moreover, although the above mentioned features of balloon 1948 may bedifferent than those of balloon 1548, cannula 1940 may be a cannulasimilar to cannula 1540.

According to some embodiments, both balloon 1548 and 1948 can bedesigned to have nearly the same OD increase in response to the sameincremental inflation volume. For instance, referring to FIGS. 15-22,V3-V2 may equal or nearly equal V7-V6, V4-V3 may equal or nearly equalV8-V7 and V4-V2 may equal or nearly equal V8-V6; D3-D2 may equal ornearly equal D7-D6, and/or D4-D3 may equal or nearly equal D8-D7 and/orD4-D2 may equal or nearly D8-D6. This effect is accomplished byshortening of the balloon length of the larger OD balloon, as discussedabove.

Also, according to embodiments, either or both balloon 1548 and 1948 canbe designed to have one or both tapered ends (e.g., ends T1, T6, and thelike) configured and/or attached to the cannula (e.g., cannula 1540 or1940) such that the attachment point of the balloon to the cannula istoward the center of the balloon and not away from the center of theballoon as is shown in FIGS. 15-22. For example, FIG. 23 iscross-sectional side views of occlusion balloons attached to cathetersand inflated by a volume of fluid. FIG. 23 shows apparatus 2300including balloon 2348 having tapered ends T9 and T10 configured and/orattached to cannula 2340, and inflated by volume of fluid V9. Apparatus2300, parts, features, functions, dimensions, design, and/or manufacturethereof may be similar to those corresponding for apparatus 1500 or1900, above, other than the orientation of tapered end T9. Thus, cannula2340 may be similar to cannula 1540 or 1940, end T10 may be similar toend T1 or T5, and volume V9 may be similar to volume V1 or V6. Also,balloon 2348 may function similarly to balloon 1548 and/or 1948 asdescribed above, other than the orientation of tapered end T9.Specifically, end T9 may be configured and/or attached to cannula 2340such that the attachment point of the balloon to the cannula is towardthe center of the balloon, as is shown in FIG. 23, and not away from thecenter of the balloon, as is shown in FIGS. 15-22. The configuration oftapered end T9 shown in FIG. 23 (e.g., balloon tapered end orientation)may be chosen to limit the compression and/or extension forces that maybe applied to the cannula between the balloon attachment points duringballoon inflation.

Similarly, FIG. 23 shows apparatus 2310 including balloon 2349 havingtapered ends T11 and T12 configured and/or attached to cannula 2340 or2350, and inflated by volume of fluid V10. Apparatus 2310, parts,features, functions, dimensions, design, and/or manufacture thereof maybe similar to those corresponding for apparatus 1500 or 1900, above,other than the orientation of tapered ends T11 and T12. Thus, cannula2350 may be similar to cannula 1540 or 1940, and volume V10 may besimilar to volume V1 or V6. Also, balloon 2349 may function similarly toballoon 1548 and/or 1948 as described above, other than the orientationof tapered ends T11 and T12. Specifically, ends T11 and T12 may beconfigured and/or attached to cannula 2350 such that the attachmentpoint of the balloon to the cannula is toward the center of the balloon,as is shown in FIG. 23, and not away from the center of the balloon, asis shown in FIGS. 15-22. The configuration of tapered ends T11 and T12shown in FIG. 23 (e.g., balloon tapered end orientation) may be chosento limit the compression and/or extension forces that may be applied tothe cannula between the balloon attachment points during ballooninflation.

In the foregoing specification, specific embodiments are described. Forexample, devices, structures, inflation-deflation devices, extensiontubes, stopcocks, catheters, cannulas, balloons, occlusion devices, andprocesses described herein may be used to treat blood vessels of a humanbeing, such as veins or arteries, including those of the human heart.However, various modifications and changes may be made thereto withoutdeparting from the broader spirit and scope of embodiments as set forthin the claims. The specification and drawings are, accordingly, to beregarded in an illustrative rather than a restrictive sense.

What is claimed is:
 1. An apparatus comprising: a flexible tube forpositioning between a syringe tube and a catheter, the flexible tubecomprising: a first end having a first connector adapted to couple theflexible tube to an output of the syringe tube; a second end having asecond connector to couple the flexible tube to an input adapter of thecatheter; an inner material defining a lumen having an inner diametersufficient to communicate fluid between the syringe tube and the inputadapter to cause a volume of fluid to inflate a balloon attached to thecatheter to occlude a blood vessel at a region of interest; and an outermaterial surrounding the inner material; wherein the inner material hasa modulus of elasticity greater than a modulus of elasticity of theouter material, wherein the inner material and the outer material aremiscible and are co-extruded, and wherein an inner diameter of the innermaterial is less than or equal to 0.035 inches, and an outer diameter ofthe outer material is greater than or equal to 0.13 inches.
 2. Theapparatus of claim 1, further comprising a stopcock having an inputadapter attached and sealed to the second connector and an outputadapter attached and sealed to the input adapter of the catheter, thestopcock having an inner diameter sufficient to communicate fluidbetween the syringe tube and the input adapter to cause a volume offluid to inflate a balloon attached to the catheter to occlude a bloodvessel at a region of interest.
 3. The apparatus of claim 1, wherein theflexible tube has a length dimension for positioning between a syringetube and the input adaptor of a catheter; wherein the first end has thefirst connector adapted to attach and seal the flexible tube to theoutput of the syringe tube; and wherein the outer material surrounds andis extruded over the inner material.
 4. The apparatus of claim 1,wherein the inner material thickness and the outer material thicknessare chosen depending upon the modulus of the inner material and themodulus of the outer material to provide the flexible tube with aselected flexibility and low compliance.
 5. The apparatus of claim 1,further comprising an intermediate adhesive polymer attaching the innermaterial to the outer material.
 6. The apparatus of claim 1, wherein theinner material is one of nylon or HDPE; wherein the outer material isone of a non-elastomeric polymer or LDPE; wherein the outer material ismiscible with inner material; and wherein the inner material hasthickness less than a thickness of the outer material.
 7. The apparatusof claim 1, wherein the inner material has a high modulus to provide lowcompliance and low volume change properties of the flexible tube; andthe outer material has a low modulus to provide support to the innermaterial to provide kink resistance and to increase the flexible tubeouter diameter to an outer diameter accepted by conventional extensiontubing connectors, while maintaining an acceptable level of flexibility.8. The apparatus of claim 1, wherein the inner material is bonded to theouter material by a bonding agent or due to their being miscible, tofacilitate the attachment of the first connector to the first end andthe second connector to the second end.
 9. The apparatus of claim 1,wherein the flexible tube has a low compliance, such that it does notexhibit a substantial change in a volume of fluid within the innerdiameter in response to (1) bends, curves, or movement of the tube, (2)grasping or holding the tube such as by a human hand, or (3) pressurechanges of the fluid within the tube, when the flexible tube is used toinflate the balloon.
 10. The apparatus of claim 1, comprising a syringetube attached to the first connector, the syringe tube to provide apressure of fluid to the input adapter to cause a volume of fluid toinflate a balloon attached to the catheter to occlude a blood vessel ata region of interest.
 11. The apparatus of claim 1, wherein the secondconnector comprises a rotating male luer attached to the second end. 12.The apparatus of claim 1, further comprising a syringe tube attached tothe first connector, and a catheter attached to the second connector,the syringe tube to provide a pressure of fluid to the input adapter tocause a volume of fluid to inflate a balloon attached to the catheter toocclude a blood vessel at a region of interest.
 13. The apparatus ofclaim 1, wherein the inner material and the outer material aretranslucent materials.
 14. A system comprising: a syringe tube attachedand sealed to a first connector on a first end of a flexible tube, thesyringe tube to provide a pressure of fluid to the input adapter tocause a volume of fluid to inflate a balloon attached to the catheter toocclude a blood vessel at a region of interest; a catheter attached andsealed to a second connector on a second end of the flexible tube, thecatheter having an inner diameter sufficient to communicate fluidbetween the syringe tube and the input adapter to cause a volume offluid to inflate a balloon attached to the catheter to occlude a bloodvessel at a region of interest; the flexible tube comprising of: aninner material defining a lumen having an inner diameter sufficient tocommunicate fluid between the syringe tube and the catheter to cause avolume of fluid to inflate a balloon attached to the catheter to occludea blood vessel at a region of interest; and an outer materialsurrounding the inner material; wherein the inner material has a modulusof elasticity greater than a modulus of elasticity of the outermaterial, wherein the inner material and the outer material are miscibleand are co-extruded, and wherein an inner diameter of the inner materialis less than or equal to 0.035 inches, and an outer diameter of theouter material is greater than or equal to 0.13 inches.
 15. The systemof claim 14, further comprising a stopcock having an input adapterattached and sealed to the second connector and an output adapterattached and sealed to the catheter.
 16. The system of claim 15, whereinthe stopcock is a two way stopcock and has another input adapterattached and sealed to an aspiration syringe.
 17. The system of claim14, wherein the flexible tube has a length dimension for positioningbetween a syringe tube and the input adaptor of a catheter; wherein thefirst end has the first connector adapted to attach and seal theflexible tube to the output of the syringe tube; and wherein the outermaterial surrounds and is extruded over the inner material.
 18. Thesystem of claim 14, wherein the inner material thickness and the outermaterial thickness are chosen depending upon the modulus of the innermaterial and the modulus of the outer material to provide the flexibletube with a selected flexibility and low compliance.
 19. The system ofclaim 14, wherein the inner material and the outer material aretranslucent materials.